QNW
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Reprocessed Bronchoscope
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.4680
- Medical specialty
- Ear, Nose, Throat
- FDA definition
- Same as EOQ except reprocessed. Please see EOQ at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=EOQ Reprocessing validation data for this device type must be included in a 510(k) submission.
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| Record | Firm | Date |
|---|---|---|
| Monarch Bronchoscope (K231473) | Auris Health, Inc., A Johnson and Johnson Family Company | 2023-11-28 |
| Monarch Bronchoscope (K203614) | Auris Health, Inc., A Johnson and Johnson Family Company | 2021-03-11 |
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Every clearance here is in the API, with alerts when new ones post.