K142103 is an FDA 510(k) clearance for the CUFF PILOT, SURE SEAL. This device is classified as a Cuff, Tracheal Tube, Inflatable (Class II - Special Controls, product code BSK).
Submitted by Teleflexmedical, Inc. (Morrisville, US). The FDA issued a Cleared decision on May 8, 2015, 280 days after receiving the submission on August 1, 2014.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5750.
| 510(k) Number | K142103 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 01, 2014 |
| Decision Date | May 08, 2015 |
| Days to Decision | 280 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BSK — Cuff, Tracheal Tube, Inflatable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5750 |