510(k) K982905 ยท FGB Ureteroscope And Accessories, Flexible/Rigid
MVM 7.5 FRENCH FLEXIBLE URETEROSCOPE
| Applicant | Karl Storz Endoscopy, Culver City CA, US |
| Decision | Substantially Equivalent, Oct 5, 1998 |
| Received | Aug 18, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982905
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 1, 2022 | Karl Storz Endoscopy 11278A2 11278AK2 Flexible Ureteroscope Z20615US-BA (08-2018);
11278AC1 N/A Flexible Ureteroscope Z17859US-A (04/2016);
11278AC2 11278ACK2 Flexible Ureteroscope Z20615US-BA (08-2018);
11278ACU1 11278AC Open, Classified |
FGB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.