510(k) K012660 ยท FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology
GIMMI'ALPHA' ENDOSCOPES & ACCESSORIES
| Applicant | Gimmi GmbH, Amsterdam, Nh, NL |
| Decision | Substantially Equivalent, Dec 20, 2001 |
| Received | Aug 13, 2001 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K012660
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 16, 2025 | Sklar Instruments ECONO STERILE medical procedure kits labeled as:
ECONO STERILE BLAKE GALLSTONE FCP CVD 8"CS25, Model Number 96-4921A Open, Classified |
HTD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.