K153470 is an FDA 510(k) clearance for the MADgic Laryngo-Tracheal Mucosal Atomization Device. This device is classified as a Applicator (laryngo-tracheal), Topical Anesthesia (Class II - Special Controls, product code CCT).
Submitted by Teleflex Medical (Morrisville, US). The FDA issued a Cleared decision on August 19, 2016, 261 days after receiving the submission on December 2, 2015.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5170.
| 510(k) Number | K153470 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 02, 2015 |
| Decision Date | August 19, 2016 |
| Days to Decision | 261 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CCT — Applicator (laryngo-tracheal), Topical Anesthesia |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5170 |