510(k) K131369 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, Nov 26, 2013 |
| Received | May 13, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131369
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 1, 2022 | Karl Storz Endoscopy 11278V 11278VK CMOS Video Ureteroscope Z17744US-A (04/2016);
11278VA 11278VAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020);
11278VU 11278VUK Flexible Video-Uretero-Renoscope (FLEX- Open, Classified |
FGB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.