510(k) K082046 ยท FBO Cystourethroscope
KARL STORZ PEDIATRIC FLEXIBLE CYSTO-URETHRO-FIBERSCOPE, MODEL 11278C1/ACUI AND CIRCON AUR-735 PEDIATRIC CYSTOURETHEROSCO
| Applicant | KARL STORZ Endoscopy-America, Inc., Culver City CA, US |
| Decision | Substantially Equivalent, Oct 10, 2008 |
| Received | Jul 18, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082046
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 1, 2022 | Karl Storz Endoscopy 11274BCU1 11274BCUK1 Flexible Cystoscope Z18449US-BD (08-2018) Open, Classified |
FAJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.