K160694 is an FDA 510(k) clearance for the Disposable Endotracheal tube, sterile, AccuCuff. This device is classified as a Tube, Tracheal (w/wo Connector) (Class II - Special Controls, product code BTR).
Submitted by Tianjin Medis Medical Device Co., Ltd. (Tianjin City, CN). The FDA issued a Cleared decision on April 7, 2017, 389 days after receiving the submission on March 14, 2016.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5730.
| 510(k) Number | K160694 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 14, 2016 |
| Decision Date | April 07, 2017 |
| Days to Decision | 389 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 |