Trokamed GmbH
GEISINGEN Baden-Wurttemberg, DE
TROKAMED GMBH appears in FDA device records in GEISINGEN Baden-Wurttemberg, DE. FDA records list 4 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 4 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for Trokamed GmbH between 2006 and 2021. The busiest year on record is 2006, with 2. The most recent is 2021, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2006 | 2 |
| 2011 | 1 |
| 2021 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K200770 | Mini PCNL-System | FED | Substantially Equivalent | |
| K091010 | TROKAMED MORCELLATOR | HET | Substantially Equivalent | |
| K060233 | TROKAMED GMBH ENDOSCOPES AND ACCESSORIES | GCJ | Substantially Equivalent | |
| K060232 | TROKAMED GMBH ELECTROSURGICAL INSTRUMENTS & ACCESSORIES | GEI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 8043746 | 3004595684 | TROKAMED GMBH | KLEINE BREITE 17, GEISINGEN Baden-Wurttemberg 78187 DE | 2026 | and 12 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- NBHAccessories, Arthroscopic
- FFYAdaptor, Bulbs, Miscellaneous, For Endoscope
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- FEDEndoscopic Access Overtube, Gastroenterology-Urology
- HTDForceps
- FCLForceps, Biopsy, Non-Electric
- NWWHysteroscope Accessories
- OARInjector, Vertebroplasty (Does Not Contain Cement)
- HCFInstrument, Ligature Passing And Knot Tying
- MDMInstrument, Manual, Surgical, General Use
- GCJLaparoscope, General & Plastic Surgery
- HETLaparoscope, Gynecologic (And Accessories)
- NWVLaparoscopic Accessories, Gynecologic
- HXBProbe
- FDCResectoscope, Working Element
- GADRetractor
- FGNRetractor, Non-Self-Retaining
- FFORetractor, Self-Retaining
- KOASurgical Instruments, G-U, Manual (And Accessories)
- FBQTrocar, Gastro-Urology
- KBGTrocar, Sinus
- KCBTube, Tonsil Suction
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0716-2025 | Sheath, 18 Fr., 160 mm (REF: WA2PS18L), 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. | Class I | Open, Classified | |
| Z-0715-2025 | Sheath, 18 Fr., 130 mm (REF: WA2PS18S), 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. | Class I | Open, Classified | |
| Z-0714-2025 | Sheath, 20 Fr., 160 mm (REF: WA2PS20L), 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. | Class I | Open, Classified | |
| Z-0713-2025 | 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. | Class I | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain