Cleared Traditional

K160200 - Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy Catheter Set
(FDA 510(k) Clearance)

K160200 · Cook Incorporated · Anesthesiology

Feb 2017

Decision

386d

Days

Class 2

Risk

K160200 is an FDA 510(k) clearance for the Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy Catheter Set, 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 review panel. Regulated under 21 CFR 868.5090.

Submission Details

510(k) Number	K160200 FDA.gov
FDA Decision	Cleared 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