Cleared Traditional

MariGen Wound Extra

K190528 · Kerecis Limited · General & Plastic Surgery
Jul 2019
Decision
128d
Days
—
Risk

About This 510(k) Submission

K190528 is an FDA 510(k) clearance for the MariGen Wound Extra, a Wound Dressing With Animal-derived Material(s), submitted by Kerecis Limited (Isafjordur, IS). The FDA issued a Cleared decision on July 10, 2019, 128 days after receiving the submission on March 4, 2019. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K190528 FDA.gov
FDA Decision Cleared SESE
Date Received March 04, 2019
Decision Date July 10, 2019
Days to Decision 128 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code KGN — Wound Dressing With Animal-derived Material(s)
Device Class —