Cleared Abbreviated

K060456 - MEDLINE COLLAGEN WOUND DRESSING

K060456 · Medline Industries, Inc. · General & Plastic Surgery device
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Jun 2006
Decision
117d
Days
-
Risk

K060456 is an FDA 510(k) clearance for the MEDLINE COLLAGEN WOUND DRESSING. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on June 19, 2006 after a review of 117 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Medline Industries, Inc. devices

FDA 510(k) Submission Details - K060456

510(k) Number K060456 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2006
Decision Date June 19, 2006
Days to Decision 117 days
Submission Type Abbreviated
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 115d · This submission: 117d
Pathway characteristics
Standards-based clearance path.

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 151
Devices cleared under the same product code (KGN) and FDA review panel - the closest regulatory comparables to K060456.
OASIS WOUND MATRIX
K061711 · Cook Biotech, Inc. · Jul 2006
PRIMATRIX DERMAL REPAIR SCAFFOLD
K061407 · Tei Biosciences, Inc. · Jun 2006
ACELL POWDER WOUND DRESSING
K060888 · Acell, Inc. · Jun 2006
COLACTIVE COLLAGEN WOUND DRESSING
K050177 · Covalontechnologies, Inc. · Apr 2005
COLLAGEN WOUND DRESSING - ORAL
K040403 · Collagen Matrix, Inc. · May 2004
MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING
K040558 · Collagen Matrix, Inc. · Mar 2004