Cleared Special

K192725 - Cytal Wound Matrix 3-Layer

K192725 · Acell, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2019
Decision
28d
Days
-
Risk

K192725 is an FDA 510(k) clearance for the Cytal Wound Matrix 3-Layer. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Acell, Inc. (Columbia, US). The FDA issued a Cleared decision on October 25, 2019 after a review of 28 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Acell, Inc. devices

Submission Details

510(k) Number K192725 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2019
Decision Date October 25, 2019
Days to Decision 28 days
Submission Type Special
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
87d faster than avg
Panel avg: 115d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 84
Devices cleared under the same product code (KGN) and FDA review panel - the closest regulatory comparables to K192725.
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K192386 · Keranetics · Jul 2020
PELNAC Bilayer Wound Matrix
K191992 · Gunze Limited · Apr 2020
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K192346 · Freudenberg Technology Innovation SE & Co. KG · Feb 2020
MariGen Wound Extra
K190528 · Kerecis Limited · Jul 2019
ProgenaMatrix
K182010 · Cell Constructs I, LLC · Jan 2019
Geistlich Derma-Gide
K182838 · Geistlich Pharma AG · Nov 2018