Cleared Traditional

MicroMatrix® Flex (K230980) - FDA 510(k) Clearance

K230980 · Acell, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Sep 2023
Decision
170d
Days
-
Risk

K230980 is an FDA 510(k) clearance for the MicroMatrix® Flex. 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 September 22, 2023 after a review of 170 days - an extended review cycle.

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 Acell, Inc. devices

Submission Details

510(k) Number K230980 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2023
Decision Date September 22, 2023
Days to Decision 170 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
55d slower than avg
Panel avg: 115d · This submission: 170d
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 K230980.
Foundation Dermal Regeneration Scaffold (DRS) Solo
K231937 · Bionova Medical, Inc. · Nov 2023
Collagen Wound Dressing
K231152 · Winner Medical Co., Ltd. · Oct 2023
SurgiAid® Collagen Wound Dressing
K223126 · Maxigen Biotech, Inc. · Oct 2023
Maxiocel Chitosan Wound Dressing
K212766 · Advamedica, Inc. · Aug 2023
NovoGen Wound Matrix
K220498 · Novabone Products, LLC · Jun 2023
FortiShield (Biosynthetic Wound Matrix)
K212579 · Organogenesis, Inc. · May 2023