Data / Medical devices / Germany / Trokamed GMBH
Trokamed GMBH: FDA-registered device maker in GEISINGEN Baden-Wurttemberg, Germany, 4 510(k) clearances
Trokamed GMBH is registered with the FDA (registration 8043746) in GEISINGEN Baden-Wurttemberg, Germany. It lists 22 device types. The FDA files 4 510(k) clearances under its listings, the newest dated July 30, 2021. 1 recall event names it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 8043746
- FEI number
- 3004595684
- Address
- Kleine Breite 17, GEISINGEN Baden-Wurttemberg, Germany, 78187
- Owner or operator
- TROKAMED GMBH (9003550)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- January 21, 2003
- Registered through
- 2026
- Brand names listed
- 02-00092, 11256-004, 11256-005, ELECTROSURGICAL INSTR, Fan Retractor, Liver Elevator, Frazer suction tube, Lowsley Retractors, Straight/Curved, MULTIPLE ACCESSORIES FOR ENDOSCOPE and more
Devices it lists
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 |
|---|---|---|---|---|---|---|
| July 30, 2021 | K200770 | Mini PCNL-System | FED | Substantially Equivalent | Trokamed GmbH | accessdata.fda.gov |
| March 1, 2011 | K091010 | TROKAMED MORCELLATOR | HET | Substantially Equivalent | Trokamed GmbH | accessdata.fda.gov |
| July 19, 2006 | K060233 | TROKAMED GMBH ENDOSCOPES AND ACCESSORIES | GCJ | Substantially Equivalent | Trokamed GmbH | accessdata.fda.gov |
| July 12, 2006 | K060232 | TROKAMED GMBH ELECTROSURGICAL INSTRUMENTS & ACCESSORIES | GEI | Substantially Equivalent | Trokamed GmbH | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| November 27, 2024 | 95770 | Class I | Ongoing | Sheath, 20 Fr., 130 mm (REF: WA2PS20S), gastroenterology-urology endoscopic access overtube. | If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fragments and kidney stone fragments, and quickly build up of intrarenal pressure. | accessdata.fda.gov |
Compare with other makers
- All makers of Endoscopic Access Overtube, Gastroenterology-Urology
- All makers of Retractor, Non-Self-Retaining
- All makers of Retractor, Self-Retaining
- All makers of Injector, Vertebroplasty (Does Not Contain Cement)
- All makers of Laparoscopic Accessories, Gynecologic
- All makers of Tube, Tonsil Suction
Updated January 10, 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.