QNW
- Product code
- QNW
- Device name
- Reprocessed Bronchoscope
- Device class
- Class 2
- 21 CFR
- 21 CFR 874.4680
- Medical specialty
- Ear, Nose, Throat
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 1
- Summaries archived here
- 1 (direct download)
- 510(k) clearances (all years, FDA)
- 2 (all years; only the last 3 years are listed here)
FDA classification 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.
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K231473 | 2023-11-28 | Auris Health, Inc., A Johnson and John… | Monarch Bronchoscope |
Official FDA classification page: QNW
Classification and pathway per current FDA publications. Data from openFDA (CC0).