Cleared Traditional

K061494 - DERMADAPT WOUND DRESSING

K061494 · Pegasus Biologics, Inc. · General & Plastic Surgery device
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Sep 2006
Decision
113d
Days
-
Risk

K061494 is an FDA 510(k) clearance for the DERMADAPT WOUND DRESSING. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Pegasus Biologics, Inc. (Irvine, US). The FDA issued a Cleared decision on September 21, 2006 after a review of 113 days - within the typical 510(k) review window.

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 Pegasus Biologics, Inc. devices

FDA 510(k) Submission Details - K061494

510(k) Number K061494 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 2006
Decision Date September 21, 2006
Days to Decision 113 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
2d faster than avg
Panel avg: 115d · This submission: 113d
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 119
Devices cleared under the same product code (KGN) and FDA review panel - the closest regulatory comparables to K061494.
PRIMATRIX DERMAL REPAIR SCAFFOLD
K083440 · Tei Biosciences, Inc. · Dec 2008
INTEGRA MESHED BILAYER WOUND MATRIX
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INTEGRA FLOWABLE WOUND MATRIX, MODEL FWD301
K072113 · Integra Lifesciences Corp. · Oct 2007
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