510(k) K200770 ยท FED Endoscopic Access Overtube, Gastroenterology-Urology
Mini PCNL-System
| Applicant | Trokamed GmbH, Geisingen, DE |
| Decision | Substantially Equivalent, Jul 30, 2021 |
| Received | Mar 25, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200770
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 10, 2025 | Trokamed GmbH Sheath, 20 Fr., 130 mm (REF: WA2PS20S), gastroenterology-urology endoscopic access overtube. Open, Classified |
FED | None listed |
| Jan 10, 2025 | Trokamed GmbH Sheath, 20 Fr., 160 mm (REF: WA2PS20L), gastroenterology-urology endoscopic access overtube. Open, Classified |
FED | None listed |
| Jan 10, 2025 | Trokamed GmbH Sheath, 18 Fr., 130 mm (REF: WA2PS18S), gastroenterology-urology endoscopic access overtube. Open, Classified |
FED | None listed |
| Jan 10, 2025 | Trokamed GmbH Sheath, 18 Fr., 160 mm (REF: WA2PS18L), gastroenterology-urology endoscopic access overtube. Open, Classified |
FED | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.