510(k) K213334 ยท FGB Ureteroscope And Accessories, Flexible/Rigid
Monarch Platform, Urology
| Applicant | Auris Health, Inc., Redwood CA, US |
| Decision | Substantially Equivalent, Apr 29, 2022 |
| Received | Oct 6, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213334
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 10, 2024 | AURIS HEALTH INC Monarch Platform (Urology), REF: MON-000007, MON-000007-RFB Open, Classified |
FGB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.