K231473 is an FDA 510(k) clearance for the Monarch Bronchoscope. This device is classified as a Reprocessed Bronchoscope (Class II - Special Controls, product code QNW).
Submitted by Auris Health, Inc., A Johnson and Johnson Family Company (Redwood, US). The FDA issued a Cleared decision on November 28, 2023, 190 days after receiving the submission on May 22, 2023.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4680. 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) Number | K231473 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 22, 2023 |
| Decision Date | November 28, 2023 |
| Days to Decision | 190 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | QNW - Reprocessed Bronchoscope |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.4680 |
| 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. |