Cleared Traditional

K841287 - DUODERM FLEXIBLE HYDROACTIVE DRESSINGS

K841287 · Convatec, A Division of E.R. Squibb & Sons · General & Plastic Surgery device
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Aug 1984
Decision
145d
Days
-
Risk

K841287 is an FDA 510(k) clearance for the DUODERM FLEXIBLE HYDROACTIVE DRESSINGS. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Convatec, A Division of E.R. Squibb & Sons (Walker, US). The FDA issued a Cleared decision on August 20, 1984 after a review of 145 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K841287

510(k) Number K841287 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1984
Decision Date August 20, 1984
Days to Decision 145 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
30d slower than avg
Panel avg: 115d · This submission: 145d
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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K841287 · DUODERM FLEXIBLE HYDROACTIVE DRESSINGS
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