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Data / Medical devices / Germany / Karl Storz Se & Co KG

Karl Storz Se & Co KG: FDA-registered device maker in TUTTLINGEN Baden-Wurttemberg, Germany, 342 510(k) clearances and 1 PMA approval

Karl Storz Se & Co KG is registered with the FDA (registration 3014342096) in TUTTLINGEN Baden-Wurttemberg, Germany. It lists 149 device types. The FDA files 342 510(k) clearances and 1 PMA approval under its listings, the newest dated October 14, 2026. Registered through 2027. FDA data exported November 3, 2026.

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Get makers like this oneWatch Karl Storz Se & Co KG
FDA registration number
3014342096
Address
Dr.-Karl-Storz-Str. 34, TUTTLINGEN Baden-Wurttemberg, Germany, 78532
Owner or operator
KARL STORZ SE & CO KG (8010119)
Roles
Specification developer
First device listed
June 20, 1978
Registered through
2027
Brand names listed
11274AB Flex Pediatric BRONCHOSCOPE, 11274AC Flex. CHOLEDOCHOSCOPE, 12G-SDI CABLE,, 26025UC HAMOU Elctrnc HYSTEROFLATOR, 300W Light Source, Non-flash, 495N Series Fibr Optic Light Cables, 7.5 Fr. Flexible CHOLEDOSCHOSCOPE, ADVANCED IMAGE AND DATA and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, ArthroscopicNBH1Specification developeraccessdata.fda.gov
Accessories, Catheter, G-UKNY2Specification developeraccessdata.fda.gov
Accessories, Cleaning Brushes, For EndoscopeMNL1Specification developeraccessdata.fda.gov
Accessories, Photographic, For Endoscope (Exclude Light Sources)FEM1Specification developeraccessdata.fda.gov
Amnioscope, Transabdominal (Fetoscope) (And Accessories)HFAfSpecification developeraccessdata.fda.gov
AngioscopeLYK2Specification developeraccessdata.fda.gov
Apparatus, Suction, Operating-Room, Wall Vacuum PoweredGCX2Specification developeraccessdata.fda.gov
ArthroscopeHRX2Specification developeraccessdata.fda.gov
Attachment, Eyepiece, For Insertion Of Prescription LensFDZ1Specification developeraccessdata.fda.gov
Basin For Endoscope ReprocessingPHT1Specification developeraccessdata.fda.gov
Biomicroscope, Slit-Lamp, Ac-PoweredHJO2Specification developeraccessdata.fda.gov
Blower, Powder, EntKCL1Specification developeraccessdata.fda.gov
Bottle, Collection And Trap, Breathing System (Uncalibrated)CBC2Specification developeraccessdata.fda.gov
Bougie, UrologicalFAX1Specification developeraccessdata.fda.gov
Bronchoscope (Flexible Or Rigid)EOQ2Specification developeraccessdata.fda.gov
Bulb, Inflation, For EndoscopeFCY1Specification developeraccessdata.fda.gov
Bur, Ear, Nose And ThroatEQJ1Specification developeraccessdata.fda.gov
Bur, Surgical, General & Plastic SurgeryGFF1Specification developeraccessdata.fda.gov
Camera, Cine, Endoscopic, With AudioFTS1Specification developeraccessdata.fda.gov
Camera, Ophthalmic, Ac-PoweredHKI2Specification developeraccessdata.fda.gov
Camera, Television, Endoscopic, Without AudioFWF1Specification developeraccessdata.fda.gov
Cannula, Surgical, General & Plastic SurgeryGEA1Specification developeraccessdata.fda.gov
Catheter And Tip, SuctionJOL2Specification developeraccessdata.fda.gov
Catheter, Balloon TypeGBA1Specification developeraccessdata.fda.gov
Chair And Table, MedicalKMN1Specification developeraccessdata.fda.gov
Choledochoscope And Accessories, Flexible/RigidFBN2Specification developeraccessdata.fda.gov
Circuit, Breathing (W Connector, Adaptor, Y Piece)CAI1Specification developeraccessdata.fda.gov
Clamp, VascularDXC2Specification developeraccessdata.fda.gov
Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)HIN2Specification developeraccessdata.fda.gov
Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)KNF2Specification developeraccessdata.fda.gov
Colonoscope And Accessories, Flexible/RigidFDF2Specification developeraccessdata.fda.gov
Confocal Optical ImagingOWN2Specification developeraccessdata.fda.gov
Container, Liquid Medication, GraduatedKYW1Specification developeraccessdata.fda.gov
Cystoscope And Accessories, Flexible/RigidFAJ2Specification developeraccessdata.fda.gov
CystourethroscopeFBO2Specification developeraccessdata.fda.gov
Dilator, Catheter, UreteralEZN2Specification developeraccessdata.fda.gov
Dilator, UrethralKOE2Specification developeraccessdata.fda.gov
Dilator, Urethral, MechanicalFAH2Specification developeraccessdata.fda.gov
Dislodger, Stone, Basket, Ureteral, MetalFFL2Specification developeraccessdata.fda.gov
Dislodger, Stone, BiliaryLQR2Specification developeraccessdata.fda.gov
Dissector, Surgical, General & Plastic SurgeryGDI1Specification developeraccessdata.fda.gov
Drape, Microscope, OphthalmicHMW2Specification developeraccessdata.fda.gov
Drape, Surgical, ExemptPUI2Specification developeraccessdata.fda.gov
Drill, Surgical, Ent (Electric Or Pneumatic) Including HandpieceERL2Specification developeraccessdata.fda.gov
Ear, Nose, And Throat Stereotaxic InstrumentPGW2Specification developeraccessdata.fda.gov
Electrode, ElectrosurgicalJOS2Specification developeraccessdata.fda.gov
Electrode, Electrosurgical, Active, UrologicalFAS2Specification developeraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Specification developeraccessdata.fda.gov
Endoscope HolderOCV2Specification developeraccessdata.fda.gov
Endoscope, Fetal Blood Sampling (And Accessories)HGK2Specification developeraccessdata.fda.gov
Endoscope, NeurologicalGWG2Specification developeraccessdata.fda.gov
Endoscope, RigidGCM2Specification developeraccessdata.fda.gov
Endoscopic Central Control UnitODA2Specification developeraccessdata.fda.gov
Endoscopic Contamination Prevention SheathODB2Specification developeraccessdata.fda.gov
Endoscopic Grasping/Cutting Instrument, Non-PoweredOCZ2Specification developeraccessdata.fda.gov
Endoscopic Injection Needle, Gastroenterology-UrologyFBK2Specification developeraccessdata.fda.gov
Endoscopic Irrigation/Suction SystemOCX2Specification developeraccessdata.fda.gov
Endoscopic Video Imaging System/Component, Gastroenterology-UrologyFET2Specification developeraccessdata.fda.gov
Esophagoscope (Flexible Or Rigid)EOX2Specification developeraccessdata.fda.gov
Evacuator, Bladder, Manually OperatedFFD1Specification developeraccessdata.fda.gov
Evacuator, Gastro-UrologyKQT2Specification developeraccessdata.fda.gov
Forceps, Biopsy, ElectricKGE2Specification developeraccessdata.fda.gov
Forceps, Biopsy, Non-ElectricFCL1Specification developeraccessdata.fda.gov
Fork, TuningGWX1Specification developeraccessdata.fda.gov
Gag, MouthKBN1Specification developeraccessdata.fda.gov
Gastroscope And Accessories, Flexible/RigidFDS2Specification developeraccessdata.fda.gov
Headlamp, Operating, Battery-OperatedHPP1Specification developeraccessdata.fda.gov
Holder, Ear SpeculumJYK1Specification developeraccessdata.fda.gov
Holder, Needle, GastroenterologicFHQ1Specification developeraccessdata.fda.gov
Hook, Microsurgical EarJYL1Specification developeraccessdata.fda.gov
Hysteroscope (And Accessories)HIH2Specification developeraccessdata.fda.gov
Hysteroscope AccessoriesNWW1Specification developeraccessdata.fda.gov
Image, Illumination, Fiberoptic, For Endoscope FFS2Specification developeraccessdata.fda.gov
Instrument, Ent Manual SurgicalLRC1Specification developeraccessdata.fda.gov
Instrument, Manual, General Obstetric-GynecologicKOH1Specification developeraccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Specification developeraccessdata.fda.gov
Instrument, MicrosurgicalGZX1Specification developeraccessdata.fda.gov
Instrument, Surgical, Non-PoweredHAO1Specification developeraccessdata.fda.gov
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentHWE1Specification developeraccessdata.fda.gov
Instruments, Dental HandDZN1Specification developeraccessdata.fda.gov
Insufflator, Automatic Carbon-Dioxide For EndoscopeFCX2Specification developeraccessdata.fda.gov
Insufflator, Endoscopic Vessel HarvestingOSV2Specification developeraccessdata.fda.gov
Insufflator, HysteroscopicHIG2Specification developeraccessdata.fda.gov
Insufflator, LaparoscopicHIF2Specification developeraccessdata.fda.gov
Kit, NephroscopeFGA2Specification developeraccessdata.fda.gov
Knife, EntKTG1Specification developeraccessdata.fda.gov
Laparoscope, General & Plastic SurgeryGCJ2Specification developeraccessdata.fda.gov
Laparoscope, Gynecologic (And Accessories)HET2Specification developeraccessdata.fda.gov
Laryngoscope, NasopharyngoscopeEQN2Specification developeraccessdata.fda.gov
Laryngoscope, Non-RigidCAL1Specification developeraccessdata.fda.gov
Laryngoscope, RigidCCW1Specification developeraccessdata.fda.gov
LaryngostroboscopeEQL1Specification developeraccessdata.fda.gov
Led Light SourceNTN2Specification developeraccessdata.fda.gov
Light Source System, Diagnostic EndoscopicOAY3Specification developeraccessdata.fda.gov
Light Source, Endoscope, Xenon ArcGCT2Specification developeraccessdata.fda.gov
Light Source, Fiberoptic, RoutineFCW2Specification developeraccessdata.fda.gov
Light Source, Photographic, FiberopticFCR2Specification developeraccessdata.fda.gov
Light, Catheter, Fiberoptic, Glass, UreteralFCS2Specification developeraccessdata.fda.gov
Light, Headband, SurgicalFSR2Specification developeraccessdata.fda.gov
Light, Surgical, AccessoriesFTA2Specification developeraccessdata.fda.gov
Lithotriptor, Electro-HydraulicFFK2Specification developeraccessdata.fda.gov
Lithotriptor, UltrasonicFEO2Specification developeraccessdata.fda.gov
Mediastinoscope, SurgicalEWY2Specification developeraccessdata.fda.gov
Microscope, SurgicalEPT1Specification developeraccessdata.fda.gov
Mirror, EntKAI1Specification developeraccessdata.fda.gov
Motor, Surgical Instrument, Ac-PoweredGEY1Specification developeraccessdata.fda.gov
Nasopharyngoscope (Flexible Or Rigid)EOB2Specification developeraccessdata.fda.gov
Nebulizer, Medicinal, Non-Ventilatory (Atomizer)CCQ1Specification developeraccessdata.fda.gov
Neurological Stereotaxic InstrumentHAW2Specification developeraccessdata.fda.gov
Obturator, For EndoscopeFEC2Specification developeraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Specification developeraccessdata.fda.gov
OtoscopeERA1Specification developeraccessdata.fda.gov
Powered Laser Surgical InstrumentGEX2Specification developeraccessdata.fda.gov
ProctoscopeGCF2Specification developeraccessdata.fda.gov
Prosthesis, Partial Ossicular ReplacementETB2Specification developeraccessdata.fda.gov
Pump, Air, Non-Manual, For EndoscopeFEQ2Specification developeraccessdata.fda.gov
Pump, Portable, Aspiration (Manual Or Powered)BTA2Specification developeraccessdata.fda.gov
Replacement, Ossicular Prosthesis, TotalETA2Specification developeraccessdata.fda.gov
ResectoscopeFJL2Specification developeraccessdata.fda.gov
Resectoscope, Working ElementFDC2Specification developeraccessdata.fda.gov
Retractor, EntKAL1Specification developeraccessdata.fda.gov
Screw, Fixation, BoneHWC2Specification developeraccessdata.fda.gov
Sigmoidoscope And Accessories, Flexible/RigidFAM2Specification developeraccessdata.fda.gov
Snare, FlexibleFDI2Specification developeraccessdata.fda.gov
Source, Carrier, Fiberoptic LightEQH1Specification developeraccessdata.fda.gov
Speculum, EntEPY1Specification developeraccessdata.fda.gov
Speculum, IlluminatedFXF1Specification developeraccessdata.fda.gov
Sterilization Wrap Containers, Trays, Cassettes & Other AccessoriesKCT2Specification developeraccessdata.fda.gov
Syringe, Irrigating (Non Dental)KYZ1Specification developeraccessdata.fda.gov
System, Digital Image Communications, RadiologicalLMD1Specification developeraccessdata.fda.gov
System, Image Processing, RadiologicalLLZ2Specification developeraccessdata.fda.gov
System, Irrigation, UrologicalLJH2Specification developeraccessdata.fda.gov
Table, Operating-Room, ElectricalGDC1Specification developeraccessdata.fda.gov
Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc UsePYO1Specification developeraccessdata.fda.gov
Telescope, Laryngeal-BronchialENZ2Specification developeraccessdata.fda.gov
Transilluminator, Fiber OpticMQW1Specification developeraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Specification developeraccessdata.fda.gov
Trocar, Gastro-UrologyFBQ2Specification developeraccessdata.fda.gov
Tube, Smoke Removal, EndoscopicFCZ1Specification developeraccessdata.fda.gov
Tubing And Tubing/Filter FitsNVT1Specification developeraccessdata.fda.gov
Tubing, NoninvasiveGAZ2Specification developeraccessdata.fda.gov
Tubing, Pressure And AccessoriesBYX1Specification developeraccessdata.fda.gov
Tubing/Tubing With Filter, Insufflation, LaparoscopicNKC1Specification developeraccessdata.fda.gov
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)KNS2Specification developeraccessdata.fda.gov
Unit, Operative DentalEIA1Specification developeraccessdata.fda.gov
Ureteroscope And Accessories, Flexible/RigidFGB2Specification developeraccessdata.fda.gov
UrethroscopeFGC2Specification developeraccessdata.fda.gov
UrethrotomeEZO2Specification developeraccessdata.fda.gov
Vaginoscope And AccessoriesMOK2Specification developeraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 342.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
October 14, 2026K260581KARL STORZ Flexible Video Neuro-EndoscopeGWGSubstantially EquivalentKarl Storz SE & CO. KGaccessdata.fda.gov
September 25, 2026K254252UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath (26205CD) Obturator (26205OC) Shaver Blade (26205SA) Shaver Blade (26205SB) Shaver Blade (091133-01/-10) Shaver Blade (091134-01/-10)HIHSubstantially EquivalentKarl Storz SE & CO. KGaccessdata.fda.gov
September 24, 2026K254303KARL STORZ SUPRALOOPKNFSubstantially EquivalentKarl Storz SE & CO. KGaccessdata.fda.gov
September 18, 2026K261102UNIDRIVE Select SystemHIHSubstantially EquivalentKarl Storz SE & CO. KGaccessdata.fda.gov
September 1, 2026K260884UNIDRIVE Select SystemGCJSubstantially EquivalentKarl Storz SE & CO. KGaccessdata.fda.gov
August 26, 2026K254103HOPKINS Telescopes for ArthroscopyHRXSubstantially EquivalentKarl Storz SE & CO. KGaccessdata.fda.gov
August 19, 2026K260209ENDOFLATOR+; Smart Smoke EvacuationHIFSubstantially EquivalentKarl Storz SE & CO. KGaccessdata.fda.gov
July 16, 2026K261706Endomat Select (UP220)HIGSubstantially EquivalentKARL STORZ SE & CO. KGaccessdata.fda.gov
June 3, 2026K252800KARL STORZ Endoscopic Accessories for UrologyOCZSubstantially EquivalentKarl Storz SE & CO. KGaccessdata.fda.gov
May 15, 2026K252624KARL STORZ Laryngoscopes and AccessoriesEQNSubstantially EquivalentKARL STORZ Endoscopy-America, Inc.accessdata.fda.gov
May 11, 2026K254228KARL STORZ Trocars with Valve SealsGCJSubstantially EquivalentKarl Storz SE & CO. KGaccessdata.fda.gov
March 2, 2026K260003KARL STORZ Mediastinoscopes and InstrumentsEWYSubstantially EquivalentKarl Storz SE & CO. KGaccessdata.fda.gov
February 26, 2026K254242KARL STORZ ICG Imaging System with RUBINA® LensOWNSubstantially EquivalentKarl Storz SE & CO. KGaccessdata.fda.gov
February 12, 2026K253972IMAGE1 (TC400US); X-to-4U Adapter (TC040)OWNSubstantially EquivalentKarl Storz SE & CO. KGaccessdata.fda.gov
December 5, 2025K251731KARL STORZ Flexible Intubation Video Endoscope – Sterile (FIVE-S) (0916612)EOQSubstantially EquivalentKarl Storz SE & CO. KGaccessdata.fda.gov
November 22, 2025K250927KARL STORZ Cholangiography SetGCJSubstantially EquivalentKarl Storz SE & CO. KGaccessdata.fda.gov
November 18, 2025K253411Miniature Telescope for Urology (27033AA)FGBSubstantially EquivalentKarl Storz SE & CO. KGaccessdata.fda.gov
September 22, 2025K250388ENDOFLATOR +HIFSubstantially EquivalentKarl Storz SE & CO. KGaccessdata.fda.gov
June 6, 2025K243550KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC)FGBSubstantially EquivalentKarl Storz SE & CO. KGaccessdata.fda.gov
May 2, 2025K244001KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ Cysto-Urethro-Fiberscope (11272C2)FBOSubstantially EquivalentKarl Storz SE & CO. KGaccessdata.fda.gov
November 27, 2024K243409KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1)FBOSubstantially EquivalentKarl Storz SE & CO. KGaccessdata.fda.gov
October 22, 2024K240506KARL STORZ HoldersOCVSubstantially EquivalentKarl Storz Endoscopy America, Inc.accessdata.fda.gov
August 1, 2024K241945KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278AC2); KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278ACU1)FGBSubstantially EquivalentKarl Storz SE & CO. KGaccessdata.fda.gov
July 25, 2024K233372KARL STORZ Fiber Telescopes for UrologyFGBSubstantially EquivalentKarl Storz SE & CO. KGaccessdata.fda.gov
June 10, 2024K232911KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S [positive deflection] (11278A2), KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S [contra-positive deflection] (11278AU1)FGBSubstantially EquivalentKarl Storz Endovision, Inc.accessdata.fda.gov
May 7, 2024K232486KARL STORZ Monopolar Resectoscopes with HF CableFJLSubstantially EquivalentKarl Storz SE & CO. KGaccessdata.fda.gov
May 1, 2024K232370Percutaneous Nephroscope SystemFGASubstantially EquivalentKarl Storz SE & CO. KGaccessdata.fda.gov
November 21, 2023K233333KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control UnitOWNSubstantially EquivalentKarl Storz SE & CO. KGaccessdata.fda.gov
November 6, 2023K232857KARL STORZ ICG Imaging SystemOWNSubstantially EquivalentKarl Storz SE & CO. KGaccessdata.fda.gov
October 3, 2023K232406KARL STORZ OR1™ SCB CONTROL (WU300)ODASubstantially EquivalentKarl Storz SE & CO. KGaccessdata.fda.gov
September 14, 2023K223885HOPKINS TelescopesHIHSubstantially EquivalentKarl Storz Endoscopy America, Inc.accessdata.fda.gov
September 8, 2023K230535KARL STORZ Urological Laser AccessoriesGEXSubstantially EquivalentKarl Storz SE & CO. KGaccessdata.fda.gov
June 23, 2023K230359KOH Ultramicro Injection Cannula (26167NN); Suction a. Irrig. Cannula,L. 36cm (37360CP); Suction a. Irrig. Cannula,L. 36cm (37360SC); Suction and Irrig Cannula,l. 36cm (37560LH); Suction a. Irrig. Cannula,L. 30cm (37260LH); KOH Ultramicro Injection Needle (26167NA); Puncture Needle, LUER-lock (26178R); Suction a. Irrig. Cannula,L. 43cm (37460LH); Suction a. Irrig. Cannula,L. 36cm (37360LH); Puncture Needle, dia. 1.6 mm, 36 cm (26175R); Two-Way Stopcock (26167H); Injection Needle, LUER-GCJSubstantially EquivalentKarl Storz Endoscopy America, Inc.accessdata.fda.gov
April 27, 2023K223520UNIDRIVE SIII SystemHIHSubstantially EquivalentKarl Storz-Endoscopy-America, Inc.accessdata.fda.gov
March 30, 2023K223923HOPKINS TelescopesGCJSubstantially EquivalentKARL STORZ Endoscopy-America, Inc.accessdata.fda.gov
March 17, 2023K221893KARL STORZ Bipolar Resectoscopes with HF CableFJLSubstantially EquivalentKarl Storz Endoscopy America, Inc.accessdata.fda.gov
December 20, 2022K221004HOPKINS TelescopesGCJSubstantially EquivalentKarl Storz Endoscopy America, Inc.accessdata.fda.gov
November 10, 2022K222504H1GCJSubstantially EquivalentKarl Storz Endoscopy America, Inc.accessdata.fda.gov
June 23, 2022K213194HD MediastinoscopeEWYSubstantially EquivalentKarl Storz Endoscopy America, Inc.accessdata.fda.gov
May 13, 2022K221174Telepack +FETSubstantially EquivalentKarl Storz Endoscopy America, Inc.accessdata.fda.gov
January 20, 2022K212458Flexible Video-Uretero-Renoscope SSU SystemFGBSubstantially EquivalentKarl Storz Endoscopy Americaaccessdata.fda.gov
December 29, 2021K212656Flexible Intubation Video Endoscope – Sterile (FIVE-S)EOQSubstantially EquivalentKarl Storz Endoscopy Americaaccessdata.fda.gov
November 15, 2021K212695KARL STORZ ICG Imaging SystemOWNSubstantially EquivalentKarl Storz Endoscopy Americaaccessdata.fda.gov
September 3, 2021K212476KARL STORZ Flexible HD Cysto-Urethroscope SystemFAJSubstantially EquivalentKarl Storz Endoscopy America, Inc.accessdata.fda.gov
May 7, 2021K203572Karl Storz Radel Sterilization TraysKCTSubstantially EquivalentKarl Storz Endoscopy America, Inc.accessdata.fda.gov
December 17, 2020K202925KARL STORZ ICG Imaging SystemOWNSubstantially EquivalentKarl Storz Endoscopy_America, Inc.accessdata.fda.gov
November 20, 2020K201526TIPCAM1 Rubina Video Endoscope SystemGCJSubstantially EquivalentKarl Storz Endoscopy Americaaccessdata.fda.gov
October 29, 2020K202957Flexible Video Cysto-Urethroscope (C-view)FAJSubstantially EquivalentKARL STORZ Endoscopy-America, Inc.accessdata.fda.gov
October 22, 2020K200318UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver HandpieceERLSubstantially EquivalentKARL STORZ Endoscopy-America, Inc.accessdata.fda.gov
September 1, 2020K201135Image1 S CCU, Image1 S 4U Camera HeadFETSubstantially EquivalentKARL STORZ Endoscopy-America, Inc.accessdata.fda.gov
August 17, 2020K201399HOPKINS ICG/NIR 10mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 5mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 4mm Ridgid Endoscope 0°, 30°, 45°, VITOM II ICG/NIR Telescope, Power LED Rubina Light Source, Foot Switch, Fiber Optic Light Cable, Image S CCU, Image S 4U Rubina Camera HeadOWNSubstantially EquivalentKarl Storz-Endoscopy-America, Inc.accessdata.fda.gov
August 11, 2020K200740HD Video Rhino LaryngoscopeEOBSubstantially EquivalentKARL STORZ Endoscopy-America, Inc.accessdata.fda.gov
July 22, 2020K201355Endomat Select, IBS Shaver Software, LicenseHIGSubstantially EquivalentKarl Storz SE & CO. KGaccessdata.fda.gov
June 23, 2020K201096CO2mbiLEDFCXSubstantially EquivalentKarl Storz Endoscopy America, Inc.accessdata.fda.gov
January 27, 2020K192090CMOS Video Rhino-Laryngoscope SSUEOBSubstantially EquivalentKarl Storz SE & CO. KGaccessdata.fda.gov
January 24, 2020K192523CMOS Video Esophagoscope SSUEOXSubstantially EquivalentKarl Storz SE & CO. KGaccessdata.fda.gov
September 18, 2019K191357Flexible HD Cysto-Urethroscope SystemFAJSubstantially EquivalentKARL STORZ Endoscopy-America, Inc.accessdata.fda.gov
April 23, 2019K182723Flexible HD Cysto-Urethroscope SystemFAJSubstantially EquivalentKARL STORZ Endoscopy-America, Inc.accessdata.fda.gov
March 22, 2019K182186CMOS Video-Rhino-Laryngoscope SystemEOBSubstantially EquivalentKARL STORZ Endoscopy-America, Inc.accessdata.fda.gov
January 18, 2019K183264Flex-THOR scopeGCJSubstantially EquivalentKARL STORZ Endoscopy-America, Inc.accessdata.fda.gov
October 31, 2018K180735Endomat SelectHIGSubstantially EquivalentKarl Storz SE & CO. KGaccessdata.fda.gov
July 18, 2018K180977KARL STORZ New Generation TrocarsGCJSubstantially EquivalentKARL STORZ Endoscopy-America, Inc.accessdata.fda.gov
April 17, 2018K180146KARL STORZ ICG Imaging SystemGWGSubstantially EquivalentKarl Storz Endoscopy America, Inc.accessdata.fda.gov
February 2, 2018K171402KARL STORZ Slim NasopharyngolaryngoscopeEOBSubstantially EquivalentKARL STORZ Endoscopy-America, Inc.accessdata.fda.gov
August 2, 2017K171717AUTOCON III 400GEISubstantially EquivalentKARL STORZ Endoscopy-America, Inc.accessdata.fda.gov
May 25, 2017K171238KARL STORZ ICG Imaging SystemOWNSubstantially EquivalentKARL STORZ Endoscopy-America, Inc.accessdata.fda.gov
May 16, 2017K170462KARL STORZ ShuntScopeGWGSubstantially EquivalentKARL STORZ Endoscopy-America, Inc.accessdata.fda.gov
March 16, 2017K162880TIPCAM 1S 3D SystemGWGSubstantially EquivalentKarl Storz Endoscopy America, Inc.accessdata.fda.gov
March 2, 2017K162410TIPCAM 1S 3D SystemEOBSubstantially EquivalentKarl Storz Endoscopy America, Inc.accessdata.fda.gov
March 2, 2017K161554ENDOFLATOR 40, ENDOFLATOR 50HIFSubstantially EquivalentKARL STORZ Endoscopy-America, Inc.accessdata.fda.gov
January 26, 2017K162882KARL STORZ ICG Imaging SystemOWNSubstantially EquivalentKARL STORZ Endoscopy-America, Inc.accessdata.fda.gov
October 21, 2016K161555KARL STORZ NAV1 Electromagnetic Navigation SystemPGWSubstantially EquivalentKarl Storz Endoscopy America, Inc.accessdata.fda.gov
September 17, 2016K161112KARL STORZ Flexible Video-Neuro-Endoscope SystemGWGSubstantially EquivalentKARL STORZ Endoscopy-America, Inc.accessdata.fda.gov
May 31, 2016K152583KARL STORZ Endoscopic ICG Imaging SystemOWNSubstantially EquivalentKARL STORZ Endoscopy-America, Inc.accessdata.fda.gov
February 1, 2016K160044Image1 SPIES SystemFETSubstantially EquivalentKarl Storz Endoscopy America, Inc.accessdata.fda.gov
January 8, 2016K150969Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II Shaver Handpiece, High Speed EC Micromotor II for use with INTRA Drill HandpiecesERLSubstantially EquivalentKarl Storz Endoscopy America, Inc.accessdata.fda.gov
November 20, 2015K150525SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 LinkHETSubstantially EquivalentKARL STORZ Endoscopy-America, Inc.accessdata.fda.gov
October 9, 2015K151044CLICKLINE Scissor Insert for Single UseGEISubstantially EquivalentKarl Storz Endoscopy America, Inc.accessdata.fda.gov
September 17, 2015K143640KSEA CMOS Camera System (C-cam)GCJSubstantially EquivalentKARL STORZ Endoscopy-America, Inc.accessdata.fda.gov
October 23, 2014K142556Flexible Video-Uretero-Choledochoscope SystemFGBSubstantially EquivalentKARL STORZ Endoscopy-America, Inc.accessdata.fda.gov
September 4, 2014K140964CALCULASE IIGEXSubstantially EquivalentKARL STORZ Endoscopy-America, Inc.accessdata.fda.gov
June 11, 2014K141250FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEMFGBSubstantially EquivalentKARL STORZ Endoscopy-America, Inc.accessdata.fda.gov
January 2, 2014K131364FLEXIBLE CMOS-VIDEO-CYSTO-URETHROSCOPEFBOSubstantially EquivalentKARL STORZ Endoscopy-America, Inc.accessdata.fda.gov
December 20, 2013K131953IMAGE1 SPIESFETSubstantially EquivalentKARL STORZ Endoscopy-America, Inc.accessdata.fda.gov
November 26, 2013K131369FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEMFGBSubstantially EquivalentKARL STORZ Endoscopy-America, Inc.accessdata.fda.gov
June 26, 2013K122983KSEA BIPOLAR ELECTRODEHINSubstantially EquivalentKARL STORZ Endoscopy-America, Inc.accessdata.fda.gov
January 25, 2013K123956POWER LED 175FCWSubstantially EquivalentKARL STORZ Endoscopy-America, Inc.accessdata.fda.gov
September 27, 2012K122096KARL STORZ NAVIGATIONPANEL UNIT (NPU) SYSTEMHAWSubstantially EquivalentKARL STORZ Endoscopy-America, Inc.accessdata.fda.gov
June 28, 2012K103467CMOS VIDEO RHINO-LARYNGOSCOPE SYSTEM MODEL 11101CMEOBSubstantially EquivalentKARL STORZ Endoscopy-America, Inc.accessdata.fda.gov
April 6, 2012K111997IMAGE1 GI CCU MODEL 22203020-114FETSubstantially EquivalentKARL STORZ Endoscopy-America, Inc.accessdata.fda.gov
January 6, 2012K111165KARL STORZ SCB / COVIDIEN FORCETRIAD INTERFACE MODULEODASubstantially EquivalentKARL STORZ Endoscopy-America, Inc.accessdata.fda.gov
August 29, 2011K103308AIDA HD CONNECT WITH SMARTSCREEN / BLU-RAY DRIVE / SMARTSCREEN WITH BLU-RAY DRIVELLZSubstantially EquivalentKARL STORZ Endoscopy-America, Inc.accessdata.fda.gov
October 18, 2010K093471KARL STORZ ARTHROPUMP POWER IRRIGATION/SUCTION PUMPHRXSubstantially EquivalentKARL STORZ Endoscopy-America, Inc.accessdata.fda.gov
April 21, 2010K100195NDS SURGICAL IMAGING, LLC FOR THE ZEROWIRE DUO WIRELESS HD VIDEO TRANSFER SYSTEM, MODEL WU-WX-WY (WHERE U=R OR T, W=P, XGCJSubstantially EquivalentNds Surgical Imagingaccessdata.fda.gov
August 18, 2009K090818KARL STORZ -ENDOSCOPE STERILIZATION TRAYS, MODELS 39402AS, 39301HCTS, 39301BSKCTSubstantially EquivalentKARL STORZ Endoscopy-America, Inc.accessdata.fda.gov
May 29, 2009K083598KARL STORZ VOICE1 SCB R-UI SPEECH CONTROL APPLICATIONODASubstantially EquivalentKARL STORZ Endoscopy-America, Inc.accessdata.fda.gov
March 30, 2009K080852KSEA ELECTRONIC CO2 ENDOFLATOR LC, MODEL 26430320-1HIFSubstantially EquivalentKARL STORZ Endoscopy-America, Inc.accessdata.fda.gov
December 18, 2008K082925XENON-100 SCB LIGHT SOURCE, MODEL 20132620GCTSubstantially EquivalentKARL STORZ Endoscopy-America, Inc.accessdata.fda.gov
October 10, 2008K082046KARL STORZ PEDIATRIC FLEXIBLE CYSTO-URETHRO-FIBERSCOPE, MODEL 11278C1/ACUI AND CIRCON AUR-735 PEDIATRIC CYSTOURETHEROSCOFBOSubstantially EquivalentKARL STORZ Endoscopy-America, Inc.accessdata.fda.gov
May 9, 2008K072410KSEA CLEARVISION II, MODEL 40334120GWGSubstantially EquivalentKARL STORZ Endoscopy-America, Inc.accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

ApprovedPMA numberDeviceProduct codeSupplementsLatest decisionSource
May 28, 2010P050027KARL STORZ PHOTODYNAMIC DIAGNOSTIC D-LIGHT C (PDD) SYSTEMOAY35October 14, 2026accessdata.fda.gov

Compare with other makers

Updated October 14, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.