K122235 is an FDA 510(k) clearance for the RUSCH TRACFLEX PLUS TRACHEOSTOMY TUBE SET. This device is classified as a Tube Tracheostomy And Tube Cuff (Class II - Special Controls, product code JOH).
Submitted by Teleflexmedical, Inc. (Durham, US). The FDA issued a Cleared decision on September 6, 2013, 407 days after receiving the submission on July 26, 2012.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5800.
| 510(k) Number | K122235 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 26, 2012 |
| Decision Date | September 06, 2013 |
| Days to Decision | 407 days |
| Submission Type | Special |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | JOH — Tube Tracheostomy And Tube Cuff |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5800 |