Monarch Bronchoscope
FDA 510(k) clearance K231473 · decided 2023-11-28
Clearance details
- K-number
- K231473
- Device name
- Monarch Bronchoscope
- Applicant
- Auris Health, Inc., A Johnson and Johnson Family Company
- Decision
- Substantially Equivalent
- Date received
- 2023-05-22
- Decision date
- 2023-11-28
- Days to decision
- 190 days
- Clearance type
- Traditional
- Product code
- QNW
- 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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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Monarch Bronchoscope (K203614) | Auris Health, Inc., A Johnson and Johnson Family Company | 2021-03-11 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| MONARCH Bronchoscope. Model Number: MBR-000211-B recall (Z-0543-2026) | Auris Health, Inc | 2025-11-19 |