Cleared Traditional

MariGen Wound Extra (K190528) - FDA 510(k) Clearance

K190528 · Kerecis Limited · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Jul 2019
Decision
128d
Days
-
Risk

K190528 is an FDA 510(k) clearance for the MariGen Wound Extra. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Kerecis Limited (Isafjordur, IS). The FDA issued a Cleared decision on July 10, 2019 after a review of 128 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Kerecis Limited devices

Submission Details

510(k) Number K190528 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 115d · This submission: 128d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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

Regulatory Peers - KGN Wound Dressing With Animal-derived Material(s)

All 73
Devices cleared under the same product code (KGN) and FDA review panel - the closest regulatory comparables to K190528.
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K191992 · Gunze Limited · Apr 2020
scaffolene CL100 Bioresorbable Collagen Matrix
K192346 · Freudenberg Technology Innovation SE & Co. KG · Feb 2020
Cytal Wound Matrix 3-Layer
K192725 · Acell, Inc. · Oct 2019
ProgenaMatrix
K182010 · Cell Constructs I, LLC · Jan 2019
Geistlich Derma-Gide
K182838 · Geistlich Pharma AG · Nov 2018
NeoMatriX Wound Matrix
K181330 · Nextgen Biologics, Inc. · Oct 2018