510(k) K160136

Flowable Wound Matrix by Cook Biotech Incorporated — Product Code KGN

K160136 is an FDA 510(k) premarket notification submitted by Cook Biotech Incorporated for the device "Flowable Wound Matrix". The FDA issued a decision of Substantially Equivalent on September 28, 2016. The device falls under product code KGN (Wound Dressing With Animal-Derived Material(S)), a Class U device. Cook Biotech Incorporated has at least 10 other 510(k) clearances on record.