Cleared Special

K061711 - OASIS WOUND MATRIX

K061711 · Cook Biotech, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2006
Decision
30d
Days
-
Risk

K061711 is an FDA 510(k) clearance for the OASIS WOUND MATRIX. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Cook Biotech, Inc. (West Lafayette, US). The FDA issued a Cleared decision on July 19, 2006 after a review of 30 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 Cook Biotech, Inc. devices

FDA 510(k) Submission Details - K061711

510(k) Number K061711 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 2006
Decision Date July 19, 2006
Days to Decision 30 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
85d faster than avg
Panel avg: 115d · This submission: 30d
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 156
Devices cleared under the same product code (KGN) and FDA review panel - the closest regulatory comparables to K061711.
MODIFICATION TO COLLAWOUND DRESSING
K070269 · Collamatrix Co., Inc. · Mar 2007
COLLAGUARD, MODEL FCIA,FCIB,FCIC,AND FCID
K061746 · Innocoll Pharmaceuticals · Oct 2006
DERMADAPT WOUND DRESSING
K061494 · Pegasus Biologics, Inc. · Sep 2006
COLLAWOUND DRESSING
K061474 · Collamatrix Co., Inc. · Jul 2006
PRIMATRIX DERMAL REPAIR SCAFFOLD
K061407 · Tei Biosciences, Inc. · Jun 2006
ACELL POWDER WOUND DRESSING
K060888 · Acell, Inc. · Jun 2006