Cleared Traditional

K931565 - MEROCEL WOUND DRESSING

K931565 is the FDA 510(k) clearance for MEROCEL WOUND DRESSING by Merocel Corp.. It is a Class 1 General & Plastic Surgery device (product code KMF) cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K931565 · Merocel Corp. · General & Plastic Surgery device
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Aug 1993
Decision
129d
Days
Class 1
Risk

K931565 is an FDA 510(k) clearance for the MEROCEL WOUND DRESSING. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Merocel Corp. (Mystic, US). The FDA issued a Cleared decision on August 6, 1993 after a review of 129 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.5090 - the FDA general and plastic surgery device framework. 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 Merocel Corp. devices

Submission Details

510(k) Number K931565 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received March 30, 1993
Decision Date August 06, 1993
Days to Decision 129 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
14d slower than avg
Panel avg: 115d · This submission: 129d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KMF Bandage, Liquid
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5090
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KMF Bandage, Liquid

All 38
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K931565.
DUODERM EXTRA THIN CGF DRESSING
K925990 · Convatec, A Division of E.R. Squibb & Sons · Oct 1993
DUODERM CGF CONTROL GEL FORMULA DRESSING & BORDER
K925991 · Convatec, A Division of E.R. Squibb & Sons · Oct 1993
DUODERM HYDROACTIVE DRESSING
K925993 · Convatec, A Division of E.R. Squibb & Sons · Oct 1993
NASAL CAVITY WOUND DRESSING
K923957 · Smith & Nephew Richards, Inc. · May 1993
COMFEEL(R) WOUND DRESSING SD
K925376 · Coloplast A/S · Mar 1993
COMFEEL WOUND DRESSING ORD
K922461 · Coloplast A/S · Aug 1992