510(k) K212476 ยท FAJ Cystoscope And Accessories, Flexible/Rigid
KARL STORZ Flexible HD Cysto-Urethroscope System
| Applicant | Karl Storz Endoscopy America, Inc., El Segundo CA, US |
| Decision | Substantially Equivalent, Sep 3, 2021 |
| Received | Aug 6, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K212476
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 1, 2022 | Karl Storz Endoscopy 11272VH-TL 11272VHK-TL HD-VIEW Flexible HD Cysto-Urethroscope Z23875US-BC (10-2021)
11272VHU-TL 11272VHUK-TL HD-VIEW Flexible HD Cysto-Urethroscope Z23875US-BC (10-2021) Open, Classified |
FBO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.