Monarch Platform
FDA 510(k) clearance K211493 · decided 2021-07-09
Clearance details
- K-number
- K211493
- Device name
- Monarch Platform
- Applicant
- Auris Health, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2021-05-13
- Decision date
- 2021-07-09
- Days to decision
- 57 days
- Clearance type
- Special
- Product code
- EOQ
- Device class
- 2
- Regulation number
- 874.4680
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Redwood, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-0000 recall (Z-1383-2026) | Auris Health, Inc | 2026-02-17 |
| Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. Monarch Platform (Bronch recall (Z-0051-2025) | AURIS HEALTH INC | 2024-10-10 |