Cleared Traditional

K990964 - SIGNADRESS DUODERM DRESSING

K990964 · Convatec, A Division of E.R. Squibb & Sons · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1999
Decision
56d
Days
-
Risk

K990964 is an FDA 510(k) clearance for the SIGNADRESS DUODERM DRESSING. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Convatec, A Division of E.R. Squibb & Sons (Skillman, US). The FDA issued a Cleared decision on May 18, 1999 after a review of 56 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 Convatec, A Division of E.R. Squibb & Sons devices

Submission Details

510(k) Number K990964 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 1999
Decision Date May 18, 1999
Days to Decision 56 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
59d faster than avg
Panel avg: 115d · This submission: 56d
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 K990964.
COLLAGEN TOPICAL WOUND DRESSING
K030921 · Collagen Matrix, Inc. · May 2003
SS MATRIX
K020732 · Cook Biotech, Inc. · May 2002
SIS WOUND DRESSING II
K993948 · Cook Biotech, Inc. · Jan 2000
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
SIS WOUND DRESSING
K973170 · Cook Biotech, Inc. · Apr 1998