Cleared Traditional

MEPITEL NON-ADHERENT SILICONE DRESSING (K914604) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K914604 · Molnlycke Clinical Products AB · General & Plastic Surgery device
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Mar 1992
Decision
160d
Days
Class 1
Risk

K914604 is an FDA 510(k) clearance for the MEPITEL NON-ADHERENT SILICONE DRESSING. Classified as Gauze / Sponge,nonresorbable For External Use (product code NAB), Class I - General Controls.

Submitted by Molnlycke Clinical Products AB (Chicago, US). The FDA issued a Cleared decision on March 25, 1992 after a review of 160 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4014 - 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 Molnlycke Clinical Products AB devices

Submission Details

510(k) Number K914604 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 1991
Decision Date March 25, 1992
Days to Decision 160 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
45d slower than avg
Panel avg: 115d · This submission: 160d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NAB Gauze / Sponge,nonresorbable For External Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4014
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 - NAB Gauze / Sponge,nonresorbable For External Use

Devices cleared under the same product code (NAB) and FDA review panel - the closest regulatory comparables to K914604.
TRICOTEX WOUND CONTACT LAYER DRESSING
K864264 · Smith & Nephew, Inc. · Dec 1986
FEMORAL CANAL SPONGE
K831886 · Zimmer, Inc. · Sep 1983
MELOLIN
K821246 · Smith & Nephew, Inc. · Aug 1982
UNIFLEX
K820470 · Howmedica Corp. · Jun 1982
BONE-DRI SURGICAL SPONGE
K803125 · Howmedica Corp. · Jan 1981
BANDAGE COMPRESS 2, 3, 4
K770410 · Johnson & Johnson Professionals, Inc. · Jun 1977