Cleared Traditional

K112580 - COLLAGEN WOUND DRESSING

K112580 · Dalim Tissen Co., Ltd. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Jun 2012
Decision
269d
Days
-
Risk

K112580 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 Dalim Tissen Co., Ltd. (Brea, US). The FDA issued a Cleared decision on June 1, 2012 after a review of 269 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 Dalim Tissen Co., Ltd. devices

FDA 510(k) Submission Details - K112580

510(k) Number K112580 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2011
Decision Date June 01, 2012
Days to Decision 269 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
154d slower than avg
Panel avg: 115d · This submission: 269d
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 115
Devices cleared under the same product code (KGN) and FDA review panel - the closest regulatory comparables to K112580.
Dental Collagen Wound Dressing (Nova Tape and NovaPlug)
K142712 · Novabone Products, LLC · Jan 2015
PRIMATRIX DERMAL REPAIR SCAFFOLD
K131286 · Tei Biosciences, Inc. · Aug 2013
COLLAGEN DENTAL WOUND DRESSINGS
K122115 · Collagen Matrix, Inc. · Nov 2012
INTEGRA WOUND MATRIX (THIN)
K113104 · Integra LifeSciences Corporation · Feb 2012
MATRISTEM WOUND MATRIX
K112409 · Acell, Inc. · Aug 2011
ACELL MATRISTEM WOUND SHEET
K092926 · Acell, Inc. · Oct 2009