510(k) K231473 ยท QNW Reprocessed Bronchoscope
Monarch Bronchoscope
| Applicant | Auris Health, Inc., A Johnson and Johnson Family Company, Redwood CA, US |
| Decision | Substantially Equivalent, Nov 28, 2023 |
| Received | May 22, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231473
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 19, 2025 | Auris Health, Inc MONARCH Bronchoscope. Model Number: MBR-000211-B Open, Classified |
QNW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.