Cleared Traditional

K973632 - DUODERM CGF CONTROL GEL FORMULA DRESSING

K973632 · Convatec, A Division of E.R. Squibb & Sons · General & Plastic Surgery device
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Dec 1997
Decision
89d
Days
-
Risk

K973632 is an FDA 510(k) clearance for the DUODERM CGF CONTROL GEL FORMULA DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Convatec, A Division of E.R. Squibb & Sons (Skillman, US). The FDA issued a Cleared decision on December 22, 1997 after a review of 89 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 K973632 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received September 24, 1997
Decision Date December 22, 1997
Days to Decision 89 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 115d · This submission: 89d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 222
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K973632.
COMPEED PSORIASIS DRESSING
K982493 · Coloplast Corp. · Jan 1999
BIATAIN FOAM DRESSING
K983163 · Coloplast Corp. · Dec 1998
BIATAIN FOAM ADHESIVE DRESSING
K983173 · Coloplast Corp. · Dec 1998
KENDALL CURITY PETROLATUM GAUZE
K973511 · Kendall Healthcare Products Co. Div.Of Tyco Health · Dec 1997
KENDALL XEROFORM PETROLATUM DRESSING (6311,6312,6313,6314,6315,6316,6317)
K973507 · Kendall Healthcare Products Co. Div.Of Tyco Health · Dec 1997
SIGNALDRESS
K962590 · Convatec, A Division of E.R. Squibb & Sons · Sep 1996