Cleared Traditional

K061746 - COLLAGUARD, MODEL FCIA,FCIB,FCIC,AND FCID

K061746 · Innocoll Pharmaceuticals · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
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.

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
Combination Product No
PCCP Authorized No
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 184
Devices cleared under the same product code (KGN) and FDA review panel - the closest regulatory comparables to K061746.
INTEGRA FLOWABLE WOUND MATRIX, MODEL FWD301
K072113 · Integra Lifesciences Corp. · Oct 2007
UNITE BIOMATRIX
K071425 · Pegasus Biologics, Inc. · Jun 2007
MODIFICATION TO COLLAWOUND DRESSING
K070269 · Collamatrix Co., Inc. · Mar 2007
DERMADAPT WOUND DRESSING
K061494 · Pegasus Biologics, Inc. · Sep 2006
OASIS WOUND MATRIX
K061711 · Cook Biotech, Inc. · Jul 2006
COLLAWOUND DRESSING
K061474 · Collamatrix Co., Inc. · Jul 2006
K061746 · COLLAGUARD, MODEL FCIA,FCIB,FCIC,AND FCID
Download PDF FDA Summary Innocoll Pharmaceutic…