Cleared Traditional

K973807 - DUODERM HYDROACTIVE PASTE

K973807 · Convatec, A Bristol-Myers Squibb Co. · General & Plastic Surgery device
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Dec 1997
Decision
78d
Days
-
Risk

K973807 is an FDA 510(k) clearance for the DUODERM HYDROACTIVE PASTE. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Convatec, A Bristol-Myers Squibb Co. (Skillman, US). The FDA issued a Cleared decision on December 23, 1997 after a review of 78 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 - K973807

510(k) Number K973807 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received October 06, 1997
Decision Date December 23, 1997
Days to Decision 78 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
37d faster than avg
Panel avg: 115d · This submission: 78d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

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