K160200 is an FDA 510(k) clearance for the Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy Catheter Set. This device is classified as a Needle, Emergency Airway (Class II - Special Controls, product code BWC).
Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on February 17, 2017, 386 days after receiving the submission on January 28, 2016.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5090.
| 510(k) Number | K160200 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 28, 2016 |
| Decision Date | February 17, 2017 |
| Days to Decision | 386 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 |