Cleared Traditional

K160136 - Flowable Wound Matrix
(FDA 510(k) Clearance)

K160136 · Cook Biotech Incorporated · General & Plastic Surgery device

Sep 2016

Decision

252d

Days

—

Risk

K160136 is an FDA 510(k) clearance for the Flowable Wound Matrix. This device is classified as a Wound Dressing With Animal-derived Material(s).

Submitted by Cook Biotech Incorporated (West Lafayetta, US). The FDA issued a Cleared decision on September 28, 2016, 252 days after receiving the submission on January 20, 2016.

This device falls under the General & Plastic Surgery FDA review panel.

Submission Details

510(k) Number	K160136 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 20, 2016
Decision Date	September 28, 2016
Days to Decision	252 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF