Cleared Traditional

K013814 - ABSORBENT ANTIMICROBIAL WOUND DRESSING

K013814 · Convatec, A Division of E.R. Squibb & Sons · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2002
Decision
217d
Days
-
Risk

K013814 is an FDA 510(k) clearance for the ABSORBENT ANTIMICROBIAL WOUND DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Convatec, A Division of E.R. Squibb & Sons (Skillman, US). The FDA issued a Cleared decision on June 21, 2002 after a review of 217 days - an extended review 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: 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.

View all Convatec, A Division of E.R. Squibb & Sons devices

Submission Details

510(k) Number K013814 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 2001
Decision Date June 21, 2002
Days to Decision 217 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
102d slower than avg
Panel avg: 115d · This submission: 217d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 222
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K022416 · Coloplast Corp. · Feb 2003
COMPEED PSORIASIS DRESSING
K982493 · Coloplast Corp. · Jan 1999
BIATAIN FOAM DRESSING
K983163 · Coloplast Corp. · Dec 1998
BIATAIN FOAM ADHESIVE DRESSING
K983173 · Coloplast Corp. · Dec 1998