Data / Medical devices / Germany / Karl Storz Se & Co. KG
Karl Storz Se & Co. KG: FDA-registered device maker in TUTTLINGEN Baden-Wurttemberg, Germany, 1 510(k) clearance
Karl Storz Se & Co. KG is registered with the FDA (registration 3006546082) in TUTTLINGEN Baden-Wurttemberg, Germany. It lists 62 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
- 3006546082
- Address
- Elsa-Brandstrom-Weg 11-21, TUTTLINGEN Baden-Wurttemberg, Germany, 78532
- 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
- ARTHROPUMP DISP, Tubing Set, Adaptors for Documentation, Arthroforce, BOUGIES and Dilators, Bipolar Coagulating Forceps, Bipolar Coagulation Electrodes, Bronchoscopes, CALCUSON and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|
| Accessories, Arthroscopic | NBH | 1 | Contract manufacturer | accessdata.fda.gov |
| Accessories, Cleaning Brushes, For Endoscope | MNL | 1 | Contract manufacturer | accessdata.fda.gov |
| Arthroscope | HRX | 2 | Contract manufacturer | accessdata.fda.gov |
| Blower, Powder, Ent | KCL | 1 | Contract manufacturer | accessdata.fda.gov |
| Bougie, Urological | FAX | 1 | Contract manufacturer | accessdata.fda.gov |
| Bronchoscope (Flexible Or Rigid) | EOQ | 2 | Contract manufacturer | accessdata.fda.gov |
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | CAI | 1 | Contract manufacturer | accessdata.fda.gov |
| Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) | KNF | 2 | Contract manufacturer | accessdata.fda.gov |
| Colonoscope And Accessories, Flexible/Rigid | FDF | 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 |
| Dilator, Catheter, Ureteral | EZN | 2 | Contract manufacturer | accessdata.fda.gov |
| Dilator, Urethral | KOE | 2 | Contract manufacturer | accessdata.fda.gov |
| Dilator, Urethral, Mechanical | FAH | 2 | Contract manufacturer | accessdata.fda.gov |
| Dissector, Surgical, General & Plastic Surgery | GDI | 1 | Contract manufacturer | accessdata.fda.gov |
| Electrode, Electrosurgical | JOS | 2 | Contract manufacturer | accessdata.fda.gov |
| Electrode, Electrosurgical, Active, Urological | FAS | 2 | Contract manufacturer | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Contract manufacturer | accessdata.fda.gov |
| Endoscope Holder | OCV | 2 | Contract manufacturer | accessdata.fda.gov |
| Endoscope, Neurological | GWG | 2 | Contract manufacturer | accessdata.fda.gov |
| Endoscopic Contamination Prevention Sheath | ODB | 2 | Contract manufacturer | accessdata.fda.gov |
| Endoscopic Grasping/Cutting Instrument, Non-Powered | OCZ | 2 | Contract manufacturer | accessdata.fda.gov |
| Esophagoscope (Flexible Or Rigid) | EOX | 2 | Contract manufacturer | accessdata.fda.gov |
| Forceps, Biopsy, Electric | KGE | 2 | Contract manufacturer | accessdata.fda.gov |
| Forceps, Biopsy, Non-Electric | FCL | 1 | Contract manufacturer | accessdata.fda.gov |
| Headlamp, Operating, Battery-Operated | HPP | 1 | Contract manufacturer | accessdata.fda.gov |
| Hysteroscope (And Accessories) | HIH | 2 | Contract manufacturer | accessdata.fda.gov |
| Hysteroscope Accessories | NWW | 1 | Contract manufacturer | accessdata.fda.gov |
| Instrument, Ent Manual Surgical | LRC | 1 | Contract manufacturer | accessdata.fda.gov |
| Instrument, Manual, General Obstetric-Gynecologic | KOH | 1 | Contract manufacturer | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Contract manufacturer | accessdata.fda.gov |
| Instrument, Surgical, Non-Powered | HAO | 1 | 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 |
| Laryngoscope, Nasopharyngoscope | EQN | 2 | Contract manufacturer | accessdata.fda.gov |
| Laryngoscope, Rigid | CCW | 1 | Contract manufacturer | accessdata.fda.gov |
| Led Light Source | NTN | 2 | Contract manufacturer | accessdata.fda.gov |
| Light Source System, Diagnostic Endoscopic | OAY | 3 | Contract manufacturer | accessdata.fda.gov |
| Light Source, Endoscope, Xenon Arc | GCT | 2 | Contract manufacturer | accessdata.fda.gov |
| Light Source, Fiberoptic, Routine | FCW | 2 | Contract manufacturer | accessdata.fda.gov |
| Light, Headband, Surgical | FSR | 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 |
| Mediastinoscope, Surgical | EWY | 2 | Contract manufacturer | accessdata.fda.gov |
| Microscope, Surgical | EPT | 1 | Contract manufacturer | accessdata.fda.gov |
| Nasopharyngoscope (Flexible Or Rigid) | EOB | 2 | Contract manufacturer | accessdata.fda.gov |
| Obturator, For Endoscope | FEC | 2 | Contract manufacturer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Contract manufacturer | accessdata.fda.gov |
| Otoscope | ERA | 1 | Contract manufacturer | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Contract manufacturer | accessdata.fda.gov |
| Proctoscope | GCF | 2 | Contract manufacturer | accessdata.fda.gov |
| Resectoscope | FJL | 2 | Contract manufacturer | accessdata.fda.gov |
| Resectoscope, Working Element | FDC | 2 | Contract manufacturer | accessdata.fda.gov |
| Sigmoidoscope And Accessories, Flexible/Rigid | FAM | 2 | Contract manufacturer | accessdata.fda.gov |
| Snare, Flexible | FDI | 2 | Contract manufacturer | accessdata.fda.gov |
| Speculum, Illuminated | FXF | 1 | Contract manufacturer | accessdata.fda.gov |
| Trocar, Gastro-Urology | FBQ | 2 | Contract manufacturer | accessdata.fda.gov |
| Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | KNS | 2 | 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 |
| Urethrotome | EZO | 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.