Cleared Traditional

DUODERM HYDROACTIVE DRESSING AND CGF DRESSINGS (K912667) - FDA 510(k) Clearance

K912667 · Convatec, A Division of E.R. Squibb & Sons · General & Plastic Surgery device
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Sep 1991
Decision
78d
Days
-
Risk

K912667 is an FDA 510(k) clearance for the DUODERM HYDROACTIVE DRESSING AND CGF DRESSINGS. Classified as Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic (product code MGQ).

Submitted by Convatec, A Division of E.R. Squibb & Sons (Princeton, US). The FDA issued a Cleared decision on September 4, 1991 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 Division of E.R. Squibb & Sons devices

Submission Details

510(k) Number K912667 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1991
Decision Date September 04, 1991
Days to Decision 78 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
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.

Device Classification

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