Cleared Traditional

K020732 - SS MATRIX

K020732 · Cook Biotech, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
May 2002
Decision
85d
Days
-
Risk

K020732 is an FDA 510(k) clearance for the SS 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 May 30, 2002 after a review of 85 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.

View all Cook Biotech, Inc. devices

Submission Details

510(k) Number K020732 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2002
Decision Date May 30, 2002
Days to Decision 85 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
30d faster than avg
Panel avg: 115d · This submission: 85d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KGN Wound Dressing With Animal-derived Material(s)
Device Class -

Regulatory Peers - KGN Wound Dressing With Animal-derived Material(s)

All 88
Devices cleared under the same product code (KGN) and FDA review panel - the closest regulatory comparables to K020732.
MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING
K040558 · Collagen Matrix, Inc. · Mar 2004
MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING
K040211 · Collagen Matrix, Inc. · Feb 2004
COLLAGEN TOPICAL WOUND DRESSING
K030921 · Collagen Matrix, Inc. · May 2003
SIS WOUND DRESSING II
K993948 · Cook Biotech, Inc. · Jan 2000
SIGNADRESS DUODERM DRESSING
K990964 · Convatec, A Division of E.R. Squibb & Sons · May 1999
HA ABSORBENT WOUND DRESSING
K984388 · Convatec, A Division of E.R. Squibb & Sons · Mar 1999