Cleared Traditional

K231152 - Collagen Wound Dressing

K231152 · Winner Medical Co., Ltd. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Oct 2023
Decision
171d
Days
-
Risk

K231152 is an FDA 510(k) clearance for the Collagen Wound Dressing. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Winner Medical Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on October 12, 2023 after a review of 171 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 Winner Medical Co., Ltd. devices

FDA 510(k) Submission Details - K231152

510(k) Number K231152 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 2023
Decision Date October 12, 2023
Days to Decision 171 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
56d slower than avg
Panel avg: 115d · This submission: 171d
Pathway characteristics
Predicate-based equivalence.

KGN Device Classification - Class 0,

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

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

All 95
Devices cleared under the same product code (KGN) and FDA review panel - the closest regulatory comparables to K231152.
MiroTract Wound Matrix
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K231937 · Bionova Medical, Inc. · Nov 2023
SurgiAid® Collagen Wound Dressing
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MicroMatrix® Flex
K230980 · Acell, Inc. · Sep 2023
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K212766 · Advamedica, Inc. · Aug 2023