510(k) K160200

Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy Catheter Set by Cook Incorporated — Product Code BWC

K160200 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy Catheter Set". The FDA issued a decision of Substantially Equivalent on February 17, 2017. The device falls under product code BWC (Needle, Emergency Airway), a Class II device regulated under 21 CFR 868.5090. Cook Incorporated has at least 10 other 510(k) clearances on record.