Cleared Traditional

K984388 - HA ABSORBENT WOUND DRESSING

K984388 · Convatec, A Division of E.R. Squibb & Sons · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1999
Decision
85d
Days
-
Risk

K984388 is an FDA 510(k) clearance for the HA ABSORBENT WOUND 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 March 3, 1999 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 Convatec, A Division of E.R. Squibb & Sons devices

Submission Details

510(k) Number K984388 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1998
Decision Date March 03, 1999
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 K984388.
SS MATRIX
K020732 · Cook Biotech, Inc. · May 2002
SIS WOUND DRESSING II
K993948 · Cook Biotech, Inc. · Jan 2000
SIGNADRESS DUODERM DRESSING
K990964 · Convatec, A Division of E.R. Squibb & Sons · May 1999
FIBRCOL PLUS COLLAGEN WOUND DRESSING WITH ALGINATE
K982597 · Johnson & Johnson Medical, Inc. · Aug 1998
SIS WOUND DRESSING
K973170 · Cook Biotech, Inc. · Apr 1998
KENDALL HYDROPHILIC POWDER WOUND DRESSING
K970266 · Kendall Healthcare Products Co. Div.Of Tyco Health · Apr 1997