Cleared Special

K040211 - MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING

K040211 · Collagen Matrix, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2004
Decision
28d
Days
-
Risk

K040211 is an FDA 510(k) clearance for the MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Collagen Matrix, Inc. (Franklin Lakes, US). The FDA issued a Cleared decision on February 27, 2004 after a review of 28 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Collagen Matrix, Inc. devices

FDA 510(k) Submission Details - K040211

510(k) Number K040211 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2004
Decision Date February 27, 2004
Days to Decision 28 days
Submission Type Special
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
87d faster than avg
Panel avg: 115d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 K040211.
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
DRESSSKIN
K023778 · Tei Biosciences, Inc. · Sep 2003
COLLAGEN TOPICAL WOUND DRESSING
K030921 · Collagen Matrix, Inc. · May 2003
ACELL UBM HYDRATED WOUND DRESSING
K022854 · Acell, Inc. · Dec 2002