510(k) K173760 ยท EOQ Bronchoscope (Flexible Or Rigid)
Monarch Endoscopy Platform (Monarch Platform)
| Applicant | Auris Surgical Robotics, Inc., San Carlos CA, US |
| Decision | Substantially Equivalent, Mar 22, 2018 |
| Received | Dec 11, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173760
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 19, 2019 | AURIS HEALTH INC Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120 Terminated |
EOQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.