FDA 510(k) K213334, Monarch Platform, Urology, by Auris Health, Inc.
FDA 510(k) K213334, Monarch Platform, Urology, by Auris Health, Inc.
| 510(k) Number | K213334 |
| Device Classification Name | Ureteroscope And Accessories, Flexible/Rigid |
| Device Name | Monarch Platform, Urology |
| Applicant | Auris Health, Inc. 150 Shoreline Dr. Redwood, CA 94065 |
| Regulation Number | 876.15 |
| Classification Product Code | FGB |
| Date Received | 10/06/2021 |
| Decision Date | 04/29/2022 |
| Decision | Substantially Equivalent (SESE) |
| Regulation Medical Specialty | Gastroenterology/Urology |
| 510k Review Panel | Gastroenterology/Urology |
| Type | Traditional |
| Reviewed by Third Party | No |
| Combination Product | No |
| Total Pages | 1000 |
| Redacted Pages | 852 |
| Unredacted Pages | 148 |
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