K130405 is an FDA 510(k) clearance for the RUSCH EASYCRIC EMERGENCY CRICOTHYROTOMY SET. This device is classified as a Needle, Emergency Airway (Class II - Special Controls, product code BWC).
Submitted by Teleflex Medical (Durham, US). The FDA issued a Cleared decision on November 6, 2013, 260 days after receiving the submission on February 19, 2013.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5090.
| 510(k) Number | K130405 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 19, 2013 |
| Decision Date | November 06, 2013 |
| Days to Decision | 260 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BWC — Needle, Emergency Airway |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5090 |