510(k) K212202 ยท FAJ Cystoscope And Accessories, Flexible/Rigid
WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope, WiScope Image System
| Applicant | OTU Medical, Inc., San Jose CA, US |
| Decision | Substantially Equivalent, Apr 13, 2022 |
| Received | Jul 14, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212202
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.