The following data is part of a premarket notification filed by Auris Health Inc with the FDA for Monarch Platform, Urology.
| Device ID | K213334 |
| 510k Number | K213334 |
| Device Name: | Monarch Platform, Urology |
| Classification | Ureteroscope And Accessories, Flexible/rigid |
| Applicant | Auris Health Inc 150 Shoreline Drive Redwood City, CA 94065 |
| Contact | Angela Wong |
| Correspondent | Angela Wong Auris Health Inc 150 Shoreline Drive Redwood City, CA 94065 |
| Product Code | FGB |
| Subsequent Product Code | FGA |
| Subsequent Product Code | GCB |
| Subsequent Product Code | LJE |
| Subsequent Product Code | LJH |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-10-06 |
| Decision Date | 2022-04-29 |