Cleared Traditional

K100574 - COLLEXA

K100574 · Innocoll Pharmaceuticals · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2010
Decision
241d
Days
-
Risk

K100574 is an FDA 510(k) clearance for the COLLEXA. 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 28, 2010 after a review of 241 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 Innocoll Pharmaceuticals devices

FDA 510(k) Submission Details - K100574

510(k) Number K100574 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2010
Decision Date October 28, 2010
Days to Decision 241 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
126d slower than avg
Panel avg: 115d · This submission: 241d
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 K100574.
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
ATLAS WOUND MATRIX
K090954 · Wrightmedicaltechnologyinc · Jul 2009
INTEGRA MESHED BILAYER WOUND MATRIX
K081635 · Integra Lifesciences Corp. · Dec 2008