Cleared Traditional

PELNAC Bilayer Wound Matrix

K191992 · Gunze Limited · General & Plastic Surgery

Apr 2020

Decision

279d

Days

—

Risk

About This 510(k) Submission

K191992 is an FDA 510(k) clearance for the PELNAC Bilayer Wound Matrix, a Wound Dressing With Animal-derived Material(s), submitted by Gunze Limited (Ayabe, Kyoto, JP). The FDA issued a Cleared decision on April 29, 2020, 279 days after receiving the submission on July 25, 2019. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number	K191992 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 25, 2019
Decision Date	April 29, 2020
Days to Decision	279 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF