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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, 6 510(k) clearances

Karl Storz Se & Co. KG is registered with the FDA (registration 9610617) in TUTTLINGEN Baden-Wurttemberg, Germany. It lists 137 device types. The FDA files 6 510(k) clearances under its listings, the newest dated August 13, 2025. 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
9610617
FEI number
3002808268
Address
Dr.-Karl-Storz-Str. 11, TUTTLINGEN Baden-Wurttemberg, Germany, 78532
Owner or operator
KARL STORZ SE & CO KG (8010119)
Roles
Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
First device listed
August 10, 1999
Registered through
2027
Brand names listed
11274AB Flex Pediatric BRONCHOSCOPE, 12G-SDI CABLE,, 26025UC HAMOU Elctrnc HYSTEROFLATOR, ADVANCED IMAGE AND DATA, AIDA Compact II System, AIDA w/ DICOM and HL7 Interface, ARTHRO PUMP, ARTHROPUMP DISP, Tubing Set and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, ArthroscopicNBH1Contract manufactureraccessdata.fda.gov
Accessories, Catheter, G-UKNY2Contract manufactureraccessdata.fda.gov
Accessories, Cleaning Brushes, For EndoscopeMNL1Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
Accessories, Photographic, For Endoscope (Exclude Light Sources)FEM1Specification developeraccessdata.fda.gov
Amnioscope, Transabdominal (Fetoscope) (And Accessories)HFAfContract manufactureraccessdata.fda.gov
AngioscopeLYK2Contract manufactureraccessdata.fda.gov
Apparatus, Suction, Operating-Room, Wall Vacuum PoweredGCX2Contract manufactureraccessdata.fda.gov
ArthroscopeHRX2Contract manufactureraccessdata.fda.gov
Basin For Endoscope ReprocessingPHT1Contract manufactureraccessdata.fda.gov
Blower, Powder, EntKCL1Contract manufactureraccessdata.fda.gov
Bottle, Collection And Trap, Breathing System (Uncalibrated)CBC2Contract manufactureraccessdata.fda.gov
Bougie, UrologicalFAX1Contract manufactureraccessdata.fda.gov
Bronchoscope (Flexible Or Rigid)EOQ2Contract manufactureraccessdata.fda.gov
Bulb, Inflation, For EndoscopeFCY1Contract manufactureraccessdata.fda.gov
Bur, Ear, Nose And ThroatEQJ1Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
Bur, Surgical, General & Plastic SurgeryGFF1Contract manufactureraccessdata.fda.gov
Camera, Television, Endoscopic, Without AudioFWF1Contract manufactureraccessdata.fda.gov
Cannula, Surgical, General & Plastic SurgeryGEA1Contract manufactureraccessdata.fda.gov
Catheter And Tip, SuctionJOL2Contract manufactureraccessdata.fda.gov
Catheter, Balloon TypeGBA1Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
Chair And Table, MedicalKMN1Contract manufactureraccessdata.fda.gov
Choledochoscope And Accessories, Flexible/RigidFBN2Contract manufactureraccessdata.fda.gov
Circuit, Breathing (W Connector, Adaptor, Y Piece)CAI1Contract manufactureraccessdata.fda.gov
Clamp, VascularDXC2Contract manufactureraccessdata.fda.gov
Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)HIN2Contract manufactureraccessdata.fda.gov
Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)KNF2Contract manufactureraccessdata.fda.gov
Colonoscope And Accessories, Flexible/RigidFDF2Contract manufactureraccessdata.fda.gov
Confocal Optical ImagingOWN2Contract manufactureraccessdata.fda.gov
Cystoscope And Accessories, Flexible/RigidFAJ2Contract manufacturer, Manufactureraccessdata.fda.gov
CystourethroscopeFBO2Contract manufactureraccessdata.fda.gov
Dilator, Catheter, UreteralEZN2Contract manufactureraccessdata.fda.gov
Dilator, UrethralKOE2Contract manufactureraccessdata.fda.gov
Dilator, Urethral, MechanicalFAH2Contract manufactureraccessdata.fda.gov
Dislodger, Stone, Basket, Ureteral, MetalFFL2Contract manufactureraccessdata.fda.gov
Dislodger, Stone, BiliaryLQR2Contract manufactureraccessdata.fda.gov
Dissector, Surgical, General & Plastic SurgeryGDI1Contract manufactureraccessdata.fda.gov
Drape, Microscope, OphthalmicHMW2Contract manufactureraccessdata.fda.gov
Drape, Surgical, ExemptPUI2Contract manufactureraccessdata.fda.gov
Drill, Surgical, Ent (Electric Or Pneumatic) Including HandpieceERL2Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
Ear, Nose, And Throat Stereotaxic InstrumentPGW2Contract manufactureraccessdata.fda.gov
Electrode, ElectrosurgicalJOS2Contract manufactureraccessdata.fda.gov
Electrode, Electrosurgical, Active, UrologicalFAS2Contract manufactureraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Contract manufactureraccessdata.fda.gov
Endoscope HolderOCV2Contract manufactureraccessdata.fda.gov
Endoscope, Fetal Blood Sampling (And Accessories)HGK2Contract manufactureraccessdata.fda.gov
Endoscope, NeurologicalGWG2Contract manufactureraccessdata.fda.gov
Endoscope, RigidGCM2Contract manufactureraccessdata.fda.gov
Endoscopic Central Control UnitODA2Contract manufactureraccessdata.fda.gov
Endoscopic Contamination Prevention SheathODB2Contract manufactureraccessdata.fda.gov
Endoscopic Grasping/Cutting Instrument, Non-PoweredOCZ2Contract manufactureraccessdata.fda.gov
Endoscopic Injection Needle, Gastroenterology-UrologyFBK2Contract manufactureraccessdata.fda.gov
Endoscopic Irrigation/Suction SystemOCX2Contract manufactureraccessdata.fda.gov
Endoscopic Video Imaging System/Component, Gastroenterology-UrologyFET2Contract manufactureraccessdata.fda.gov
Esophagoscope (Flexible Or Rigid)EOX2Contract manufactureraccessdata.fda.gov
Evacuator, Bladder, Manually OperatedFFD1Contract manufactureraccessdata.fda.gov
Evacuator, Gastro-UrologyKQT2Contract manufacturer, Manufactureraccessdata.fda.gov
Forceps, Biopsy, ElectricKGE2Contract manufactureraccessdata.fda.gov
Forceps, Biopsy, Non-ElectricFCL1Contract manufactureraccessdata.fda.gov
Fork, TuningGWX1Contract manufactureraccessdata.fda.gov
Gag, MouthKBN1Contract manufactureraccessdata.fda.gov
Gastroscope And Accessories, Flexible/RigidFDS2Contract manufactureraccessdata.fda.gov
Headlamp, Operating, Battery-OperatedHPP1Contract manufactureraccessdata.fda.gov
Holder, Needle, GastroenterologicFHQ1Contract manufactureraccessdata.fda.gov
Hook, Microsurgical EarJYL1Contract manufactureraccessdata.fda.gov
Hysteroscope (And Accessories)HIH2Contract manufactureraccessdata.fda.gov
Hysteroscope AccessoriesNWW1Contract manufactureraccessdata.fda.gov
Instrument, Ent Manual SurgicalLRC1Contract manufactureraccessdata.fda.gov
Instrument, Manual, General Obstetric-GynecologicKOH1Contract manufactureraccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Contract manufactureraccessdata.fda.gov
Instrument, MicrosurgicalGZX1Contract manufactureraccessdata.fda.gov
Instrument, Surgical, Non-PoweredHAO1Contract manufactureraccessdata.fda.gov
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentHWE1Contract manufactureraccessdata.fda.gov
Instruments, Dental HandDZN1Contract manufactureraccessdata.fda.gov
Insufflator, Automatic Carbon-Dioxide For EndoscopeFCX2Contract manufactureraccessdata.fda.gov
Insufflator, Endoscopic Vessel HarvestingOSV2Contract manufactureraccessdata.fda.gov
Insufflator, HysteroscopicHIG2Contract manufactureraccessdata.fda.gov
Insufflator, LaparoscopicHIF2Contract manufactureraccessdata.fda.gov
Kit, NephroscopeFGA2Contract manufactureraccessdata.fda.gov
Laparoscope, General & Plastic SurgeryGCJ2Contract manufactureraccessdata.fda.gov
Laparoscope, Gynecologic (And Accessories)HET2Contract manufactureraccessdata.fda.gov
Laryngoscope, NasopharyngoscopeEQN2Contract manufactureraccessdata.fda.gov
Laryngoscope, Non-RigidCAL1Contract manufactureraccessdata.fda.gov
Laryngoscope, RigidCCW1Contract manufactureraccessdata.fda.gov
LaryngostroboscopeEQL1Contract manufactureraccessdata.fda.gov
Led Light SourceNTN2Contract manufactureraccessdata.fda.gov
Light Source System, Diagnostic EndoscopicOAY3Contract manufactureraccessdata.fda.gov
Light Source, Endoscope, Xenon ArcGCT2Contract manufactureraccessdata.fda.gov
Light Source, Fiberoptic, RoutineFCW2Contract manufactureraccessdata.fda.gov
Light, Catheter, Fiberoptic, Glass, UreteralFCS2Contract manufactureraccessdata.fda.gov
Light, Headband, SurgicalFSR2Contract manufactureraccessdata.fda.gov
Light, Surgical, AccessoriesFTA2Contract manufactureraccessdata.fda.gov
Lithotriptor, Electro-HydraulicFFK2Contract manufactureraccessdata.fda.gov
Lithotriptor, UltrasonicFEO2Contract manufactureraccessdata.fda.gov
Mediastinoscope, SurgicalEWY2Contract manufactureraccessdata.fda.gov
Microscope, SurgicalEPT1Contract manufactureraccessdata.fda.gov
Mirror, EntKAI1Contract manufactureraccessdata.fda.gov
Motor, Surgical Instrument, Ac-PoweredGEY1Contract manufactureraccessdata.fda.gov
Nasopharyngoscope (Flexible Or Rigid)EOB2Contract manufactureraccessdata.fda.gov
Nebulizer, Medicinal, Non-Ventilatory (Atomizer)CCQ1Contract manufactureraccessdata.fda.gov
Neurological Stereotaxic InstrumentHAW2Contract manufactureraccessdata.fda.gov
Obturator, For EndoscopeFEC2Contract manufactureraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Contract manufactureraccessdata.fda.gov
OtoscopeERA1Contract manufactureraccessdata.fda.gov
Powered Laser Surgical InstrumentGEX2Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
ProctoscopeGCF2Contract manufactureraccessdata.fda.gov
Prosthesis, Partial Ossicular ReplacementETB2Repackager or relabeleraccessdata.fda.gov
Pump, Air, Non-Manual, For EndoscopeFEQ2Contract manufactureraccessdata.fda.gov
Pump, Portable, Aspiration (Manual Or Powered)BTA2Contract manufactureraccessdata.fda.gov
Replacement, Ossicular Prosthesis, TotalETA2Repackager or relabeleraccessdata.fda.gov
ResectoscopeFJL2Contract manufactureraccessdata.fda.gov
Resectoscope, Working ElementFDC2Contract manufactureraccessdata.fda.gov
Retractor, EntKAL1Contract manufactureraccessdata.fda.gov
Screw, Fixation, BoneHWC2Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
Sigmoidoscope And Accessories, Flexible/RigidFAM2Contract manufactureraccessdata.fda.gov
Snare, FlexibleFDI2Contract manufactureraccessdata.fda.gov
Source, Carrier, Fiberoptic LightEQH1Contract manufactureraccessdata.fda.gov
Speculum, EntEPY1Contract manufactureraccessdata.fda.gov
Sterilization Wrap Containers, Trays, Cassettes & Other AccessoriesKCT2Contract manufacturer, Specification developeraccessdata.fda.gov
Syringe, Irrigating (Non Dental)KYZ1Contract manufactureraccessdata.fda.gov
System, Digital Image Communications, RadiologicalLMD1Contract manufactureraccessdata.fda.gov
System, Image Processing, RadiologicalLLZ2Contract manufactureraccessdata.fda.gov
System, Irrigation, UrologicalLJH2Contract manufactureraccessdata.fda.gov
Table, Operating-Room, ElectricalGDC1Contract manufactureraccessdata.fda.gov
Telescope, Laryngeal-BronchialENZ2Contract manufactureraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Contract manufactureraccessdata.fda.gov
Trocar, Gastro-UrologyFBQ2Contract manufactureraccessdata.fda.gov
Tube, Smoke Removal, EndoscopicFCZ1Contract manufactureraccessdata.fda.gov
Tubing And Tubing/Filter FitsNVT1Contract manufactureraccessdata.fda.gov
Tubing, NoninvasiveGAZ2Contract manufactureraccessdata.fda.gov
Tubing, Pressure And AccessoriesBYX1Contract manufactureraccessdata.fda.gov
Tubing/Tubing With Filter, Insufflation, LaparoscopicNKC1Contract manufactureraccessdata.fda.gov
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)KNS2Contract manufactureraccessdata.fda.gov
Unit, Operative DentalEIA1Contract manufactureraccessdata.fda.gov
Ureteroscope And Accessories, Flexible/RigidFGB2Contract manufactureraccessdata.fda.gov
UrethroscopeFGC2Contract manufactureraccessdata.fda.gov
UrethrotomeEZO2Contract manufactureraccessdata.fda.gov
Vaginoscope And AccessoriesMOK2Contract manufactureraccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
August 13, 2025K243653KARL STORZ HOPKINS Telescopes for UrologyFAJSubstantially EquivalentKarl Storz SE & CO. KGaccessdata.fda.gov
July 6, 2021K203198KARL STORZ Metal Sterilization TraysKCTSubstantially EquivalentKarl Storz Endoscopy America, Inc.accessdata.fda.gov
January 23, 2006K052680CALCULASE HOLMIUM LASER SYSTEM AND ACCESSORIESGEXSubstantially EquivalentKARL STORZ Endoscopy-America, Inc.accessdata.fda.gov
January 24, 2005K043375FISCH TITANIUM MIDDLE EAR PROSTHESESETASubstantially EquivalentKarl Storz Endoscopyaccessdata.fda.gov
February 26, 2002K013107BIOABSORBABLE INTERFERENCE SCREW MEGAFIXHWCSubstantially EquivalentKarl Storz Endoscopyaccessdata.fda.gov
March 24, 1995K950964KARL STORZ INTRA-HANDPIECES AND ACCESSORIESERLSubstantially EquivalentKARL STORZ Endoscopy-America, Inc.accessdata.fda.gov

Compare with other makers

Updated August 13, 2025. 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.