Cleared Traditional

K973688 - DUODERM CONTROL GEL FORMULA BORDER DRESSING

K973688 · Convatec, Ltd. · General & Plastic Surgery device
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Dec 1997
Decision
88d
Days
-
Risk

K973688 is an FDA 510(k) clearance for the DUODERM CONTROL GEL FORMULA BORDER DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Convatec, Ltd. (Skillman, US). The FDA issued a Cleared decision on December 23, 1997 after a review of 88 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, Ltd. devices

FDA 510(k) Submission Details - K973688

510(k) Number K973688 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received September 26, 1997
Decision Date December 23, 1997
Days to Decision 88 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
27d faster than avg
Panel avg: 115d · This submission: 88d
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 226
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KENDALL CURITY PETROLATUM GAUZE
K973511 · Kendall Healthcare Products Co. Div.Of Tyco Health · Dec 1997
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K973507 · Kendall Healthcare Products Co. Div.Of Tyco Health · Dec 1997