Cleared Traditional

K072113 - INTEGRA FLOWABLE WOUND MATRIX, MODEL FWD301

K072113 · Integra Lifesciences Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2007
Decision
70d
Days
-
Risk

K072113 is an FDA 510(k) clearance for the INTEGRA FLOWABLE WOUND MATRIX, MODEL FWD301. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Integra Lifesciences Corp. (Plainsboro, US). The FDA issued a Cleared decision on October 10, 2007 after a review of 70 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K072113

510(k) Number K072113 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2007
Decision Date October 10, 2007
Days to Decision 70 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
45d faster than avg
Panel avg: 115d · This submission: 70d
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 194
Devices cleared under the same product code (KGN) and FDA review panel - the closest regulatory comparables to K072113.
LTM WOUND DRESSING
K082103 · Lifecell Corp. · Oct 2008
COLLIEVA
K081782 · Innocoll Pharmaceuticals · Sep 2008
NOCC HYDROPHILIC WOUND DRESSING
K080010 · Kytogenics, Inc. · Mar 2008
UNITE BIOMATRIX
K071425 · Pegasus Biologics, Inc. · Jun 2007
MODIFICATION TO COLLAWOUND DRESSING
K070269 · Collamatrix Co., Inc. · Mar 2007
COLLAGUARD, MODEL FCIA,FCIB,FCIC,AND FCID
K061746 · Innocoll Pharmaceuticals · Oct 2006
K072113 · INTEGRA FLOWABLE WOUND MATRIX, MODEL FWD301
Download PDF FDA Summary Integra Lifesciences …