Cleared Traditional

K993948 - SIS WOUND DRESSING II

K993948 · Cook Biotech, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Jan 2000
Decision
45d
Days
-
Risk

K993948 is an FDA 510(k) clearance for the SIS WOUND DRESSING II. 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 January 6, 2000 after a review of 45 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 K993948 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 1999
Decision Date January 06, 2000
Days to Decision 45 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
70d faster than avg
Panel avg: 115d · This submission: 45d
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 K993948.
MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING
K040211 · Collagen Matrix, Inc. · Feb 2004
COLLAGEN TOPICAL WOUND DRESSING
K030921 · Collagen Matrix, Inc. · May 2003
SS MATRIX
K020732 · Cook Biotech, Inc. · May 2002
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
FIBRCOL PLUS COLLAGEN WOUND DRESSING WITH ALGINATE
K982597 · Johnson & Johnson Medical, Inc. · Aug 1998