K213028 is an FDA 510(k) clearance for the Tenax Laser Resistant Endotracheal Tube. This device is classified as a Tube, Tracheal (w/wo Connector) (Class II - Special Controls, product code BTR).
Submitted by Bryan Medical, Inc. (Cincinnati, US). The FDA issued a Cleared decision on October 21, 2021, 30 days after receiving the submission on September 21, 2021.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5730.
| 510(k) Number | K213028 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 21, 2021 |
| Decision Date | October 21, 2021 |
| Days to Decision | 30 days |
| Submission Type | Special |
| 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 |