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
| Device | Product code | Class | Role | Source |
|---|
| Apparatus, Suction, Operating-Room, Wall Vacuum Powered | GCX | 2 | Contract manufacturer | accessdata.fda.gov |
| Arthroscope | HRX | 2 | Contract manufacturer | accessdata.fda.gov |
| Confocal Optical Imaging | OWN | 2 | Contract manufacturer | accessdata.fda.gov |
| Cystoscope And Accessories, Flexible/Rigid | FAJ | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Cystourethroscope | FBO | 2 | Contract manufacturer | accessdata.fda.gov |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | ERL | 2 | Contract manufacturer | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Contract manufacturer | accessdata.fda.gov |
| Endoscope, Neurological | GWG | 2 | Contract manufacturer | accessdata.fda.gov |
| Endoscopic Central Control Unit | ODA | 2 | Contract manufacturer | accessdata.fda.gov |
| Endoscopic Grasping/Cutting Instrument, Non-Powered | OCZ | 2 | Contract manufacturer | accessdata.fda.gov |
| Endoscopic Irrigation/Suction System | OCX | 2 | Contract manufacturer | accessdata.fda.gov |
| Endoscopic Video Imaging System/Component, Gastroenterology-Urology | FET | 2 | Contract manufacturer | accessdata.fda.gov |
| Esophagoscope (Flexible Or Rigid) | EOX | 2 | Contract manufacturer | accessdata.fda.gov |
| Hysteroscope (And Accessories) | HIH | 2 | Contract manufacturer | accessdata.fda.gov |
| Insufflator, Automatic Carbon-Dioxide For Endoscope | FCX | 2 | Contract manufacturer | accessdata.fda.gov |
| Insufflator, Endoscopic Vessel Harvesting | OSV | 2 | Contract manufacturer | accessdata.fda.gov |
| Insufflator, Hysteroscopic | HIG | 2 | Contract manufacturer | accessdata.fda.gov |
| Insufflator, Laparoscopic | HIF | 2 | Contract manufacturer | accessdata.fda.gov |
| Kit, Nephroscope | FGA | 2 | Contract manufacturer | accessdata.fda.gov |
| Laparoscope, General & Plastic Surgery | GCJ | 2 | Contract manufacturer | accessdata.fda.gov |
| Laparoscope, Gynecologic (And Accessories) | HET | 2 | Contract manufacturer | accessdata.fda.gov |
| Laryngostroboscope | EQL | 1 | Contract manufacturer | accessdata.fda.gov |
| Led Light Source | NTN | 2 | Contract manufacturer | accessdata.fda.gov |
| Light Source, Endoscope, Xenon Arc | GCT | 2 | Contract manufacturer | accessdata.fda.gov |
| Light, Surgical, Accessories | FTA | 2 | Contract manufacturer | accessdata.fda.gov |
| Lithotriptor, Electro-Hydraulic | FFK | 2 | Contract manufacturer | accessdata.fda.gov |
| Lithotriptor, Ultrasonic | FEO | 2 | Contract manufacturer | accessdata.fda.gov |
| Nasopharyngoscope (Flexible Or Rigid) | EOB | 2 | Contract manufacturer | accessdata.fda.gov |
| Otoscope | ERA | 1 | Contract manufacturer | accessdata.fda.gov |
| Pump, Portable, Aspiration (Manual Or Powered) | BTA | 2 | Contract manufacturer | accessdata.fda.gov |
| System, Irrigation, Urological | LJH | 2 | Contract manufacturer | accessdata.fda.gov |
| Telescope, Laryngeal-Bronchial | ENZ | 2 | Contract manufacturer | accessdata.fda.gov |
| Tube, Smoke Removal, Endoscopic | FCZ | 1 | Contract manufacturer | accessdata.fda.gov |
| Tubing And Tubing/Filter Fits | NVT | 1 | Contract manufacturer | accessdata.fda.gov |
| Tubing, Noninvasive | GAZ | 2 | Contract manufacturer | accessdata.fda.gov |
| Tubing/Tubing With Filter, Insufflation, Laparoscopic | NKC | 1 | Contract manufacturer | accessdata.fda.gov |
| Ureteroscope And Accessories, Flexible/Rigid | FGB | 2 | Contract manufacturer | accessdata.fda.gov |
| Urethroscope | FGC | 2 | Contract manufacturer | accessdata.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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|
| August 13, 2025 | K243653 | KARL STORZ HOPKINS Telescopes for Urology | FAJ | Substantially Equivalent | Karl Storz SE & CO. KG | 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.