510(k) K141250 ยท FGB Ureteroscope And Accessories, Flexible/Rigid
FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEM
| Applicant | KARL STORZ Endoscopy-America, Inc., El Segundo CA, US |
| Decision | Substantially Equivalent, Jun 11, 2014 |
| Received | May 14, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K141250
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 1, 2022 | Karl Storz Endoscopy 11278VSA 11278VSAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020);
11278VSE 11278VSEK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020);
11278VSU 11278VSUK Flexible Vi Open, Classified |
FGB | None listed |
| Apr 1, 2022 | Karl Storz Endoscopy 11278VSA 11278VSAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020);
11278VSE 11278VSEK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020);
11278VSU 11278VSUK Flexible Vi Open, Classified |
FGB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.