510(k) K202957 ยท FAJ Cystoscope And Accessories, Flexible/Rigid
Flexible Video Cysto-Urethroscope (C-view)
| Applicant | KARL STORZ Endoscopy-America, Inc., El Segundo CA, US |
| Decision | Substantially Equivalent, Oct 29, 2020 |
| Received | Sep 30, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K202957
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 3, 2022 | Karl Storz Endoscopy STORZ KARL STORZ-ENDOSKOPE
REF 11272VUE CMOS Video Cysto-Urethroscope
REF 11272VUEK CMOS Video Cysto-Urethroscope C-VIEW KIT
REF 11272VUE-R CMOS Video Cysto-Urethroscope
REF 11272VUEK-R CMOS Video C Open, Classified |
FAJ | None listed |
| Apr 1, 2022 | Karl Storz Endoscopy 11272VUE 11272VUEK Flexible Video Cysto-Urethroscope 96136031USCA V1.1 (04/2021);
11272VUE-R 11272VUEK-R Flexible Video Cysto-Urethroscope 96136031USCA V1.1 (04/2021) Open, Classified |
FBO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.