Cleared Traditional

K973716 - DUODERM EXTRA THIN CGF DRESSING

K973716 · Convatec, A Bristol-Myers Squibb Co. · General & Plastic Surgery device
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Dec 1997
Decision
79d
Days
-
Risk

K973716 is an FDA 510(k) clearance for the DUODERM EXTRA THIN CGF DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Convatec, A Bristol-Myers Squibb Co. (Greensboro, US). The FDA issued a Cleared decision on December 17, 1997 after a review of 79 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 Bristol-Myers Squibb Co. devices

FDA 510(k) Submission Details - K973716

510(k) Number K973716 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received September 29, 1997
Decision Date December 17, 1997
Days to Decision 79 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 115d · This submission: 79d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 227
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K973716.
BIATAIN FOAM DRESSING
K983163 · Coloplast Corp. · Dec 1998
BIATAIN FOAM ADHESIVE DRESSING
K983173 · Coloplast Corp. · Dec 1998
DUODERM CGF CONTROL GEL FORMULA DRESSING
K973632 · Convatec, A Division of E.R. Squibb & Sons · Dec 1997
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