K203614 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 March 11, 2021, 91 days after receiving the submission on December 10, 2020.
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 | K203614 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 10, 2020 |
| Decision Date | March 11, 2021 |
| Days to Decision | 91 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. |