Cleared Traditional

K061746 - COLLAGUARD

K061746 · Innocoll Pharmaceuticals · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Oct 2006
Decision
103d
Days
-
Risk

K061746 is an FDA 510(k) clearance for the COLLAGUARD, MODEL FCIA,FCIB,FCIC,AND FCID. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Innocoll Pharmaceuticals (Athlone, Co. Westmeath, IE). The FDA issued a Cleared decision on October 2, 2006 after a review of 103 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 Innocoll Pharmaceuticals devices

FDA 510(k) Submission Details - K061746

510(k) Number K061746 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2006
Decision Date October 02, 2006
Days to Decision 103 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
12d faster than avg
Panel avg: 115d · This submission: 103d
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 105
Devices cleared under the same product code (KGN) and FDA review panel - the closest regulatory comparables to K061746.
ATLAS WOUND MATRIX
K090954 · Wrightmedicaltechnologyinc · Jul 2009
INTEGRA MESHED BILAYER WOUND MATRIX
K081635 · Integra Lifesciences Corp. · Dec 2008
INTEGRA FLOWABLE WOUND MATRIX, MODEL FWD301
K072113 · Integra Lifesciences Corp. · Oct 2007
OASIS WOUND MATRIX
K061711 · Cook Biotech, Inc. · Jul 2006
ACELL POWDER WOUND DRESSING
K060888 · Acell, Inc. · Jun 2006
MEDLINE COLLAGEN WOUND DRESSING
K060456 · Medline Industries, Inc. · Jun 2006