Cleared Traditional

K973806 - DUODERM HYDROACTIVE GEL

K973806 · Convatec, A Bristol-Myers Squibb Co. · General & Plastic Surgery device
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Dec 1997
Decision
84d
Days
-
Risk

K973806 is an FDA 510(k) clearance for the DUODERM HYDROACTIVE GEL. Classified as Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic (product code MGQ).

Submitted by Convatec, A Bristol-Myers Squibb Co. (Skillman, US). The FDA issued a Cleared decision on December 29, 1997 after a review of 84 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 - K973806

510(k) Number K973806 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received October 06, 1997
Decision Date December 29, 1997
Days to Decision 84 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
31d faster than avg
Panel avg: 115d · This submission: 84d
Pathway characteristics
Predicate-based equivalence.

MGQ Device Classification - Class 0,

Product Code MGQ Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic
Device Class -

Regulatory Peers - MGQ Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic

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Devices cleared under the same product code (MGQ) and FDA review panel - the closest regulatory comparables to K973806.
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AQUA PATCH
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AMERIGEL OINTMENT SATURATED WOUND DRESSING
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