K082038 is an FDA 510(k) clearance for the CLARUS VIDEO AIRWAY ENDOSCOPE, MODELS 30000-V AND 30003-V. This device is classified as a Tube, Tracheal (w/wo Connector) (Class II - Special Controls, product code BTR).
Submitted by Clarus Medical, LLC (Golden Valley, US). The FDA issued a Cleared decision on April 28, 2009, 285 days after receiving the submission on July 17, 2008.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5730.
| 510(k) Number | K082038 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 17, 2008 |
| Decision Date | April 28, 2009 |
| Days to Decision | 285 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BTR — Tube, Tracheal (w/wo Connector) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5730 |