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Data / Medical devices / Switzerland / Storz Endoskop Produktions GMBH

Storz Endoskop Produktions GMBH: FDA-registered device maker in Schaffhausen, Switzerland, 1 510(k) clearance

Storz Endoskop Produktions GMBH is registered with the FDA (registration 9614434) in Schaffhausen, Switzerland. It lists 38 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 13, 2025. Registered through 2027. FDA data exported November 3, 2026.

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FDA registration number
9614434
FEI number
3002808273
Address
Schneckenackerstrasse 1, Schaffhausen, Switzerland, CH-8200
Owner or operator
KARL STORZ SE & CO KG (8010119)
Roles
Contract manufacturer, Manufacturer
First device listed
August 10, 1999
Registered through
2027
Brand names listed
26025UC HAMOU Elctrnc HYSTEROFLATOR, ARTHRO PUMP, ARTHROPUMP Plus, Arthroscopic Telescopes, Autocon II 400 Electrosurgical Gen, CALCUSON, CALCUSPLIT, CLEARVISION Lens Irrigation System and more

Devices it lists

DeviceProduct codeClassRoleSource
Apparatus, Suction, Operating-Room, Wall Vacuum PoweredGCX2Contract manufactureraccessdata.fda.gov
ArthroscopeHRX2Contract manufactureraccessdata.fda.gov
Confocal Optical ImagingOWN2Contract manufactureraccessdata.fda.gov
Cystoscope And Accessories, Flexible/RigidFAJ2Contract manufacturer, Manufactureraccessdata.fda.gov
CystourethroscopeFBO2Contract manufactureraccessdata.fda.gov
Drill, Surgical, Ent (Electric Or Pneumatic) Including HandpieceERL2Contract manufactureraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Contract manufactureraccessdata.fda.gov
Endoscope, NeurologicalGWG2Contract manufactureraccessdata.fda.gov
Endoscopic Central Control UnitODA2Contract manufactureraccessdata.fda.gov
Endoscopic Grasping/Cutting Instrument, Non-PoweredOCZ2Contract 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
Hysteroscope (And Accessories)HIH2Contract 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
LaryngostroboscopeEQL1Contract manufactureraccessdata.fda.gov
Led Light SourceNTN2Contract manufactureraccessdata.fda.gov
Light Source, Endoscope, Xenon ArcGCT2Contract manufactureraccessdata.fda.gov
Light, Surgical, AccessoriesFTA2Contract manufactureraccessdata.fda.gov
Lithotriptor, Electro-HydraulicFFK2Contract manufactureraccessdata.fda.gov
Lithotriptor, UltrasonicFEO2Contract manufactureraccessdata.fda.gov
Nasopharyngoscope (Flexible Or Rigid)EOB2Contract manufactureraccessdata.fda.gov
OtoscopeERA1Contract manufactureraccessdata.fda.gov
Pump, Portable, Aspiration (Manual Or Powered)BTA2Contract manufactureraccessdata.fda.gov
System, Irrigation, UrologicalLJH2Contract manufactureraccessdata.fda.gov
Telescope, Laryngeal-BronchialENZ2Contract manufactureraccessdata.fda.gov
Tube, Smoke Removal, EndoscopicFCZ1Contract manufactureraccessdata.fda.gov
Tubing And Tubing/Filter FitsNVT1Contract manufactureraccessdata.fda.gov
Tubing, NoninvasiveGAZ2Contract manufactureraccessdata.fda.gov
Tubing/Tubing With Filter, Insufflation, LaparoscopicNKC1Contract manufactureraccessdata.fda.gov
Ureteroscope And Accessories, Flexible/RigidFGB2Contract manufactureraccessdata.fda.gov
UrethroscopeFGC2Contract 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

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.