Cleared Traditional

K974354 - MEPIFORM ADHERENT SILICONE DRESSING FOR SCAR CARE

K974354 is an FDA 510(k) clearance for MEPIFORM ADHERENT SILICONE DRESSING FOR..., manufactured by Sca Molnlycke. The device is a Class 1 General & Plastic Surgery device with product code MDA cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K974354 · Sca Molnlycke · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1998
Decision
106d
Days
Class 1
Risk

K974354 is an FDA 510(k) clearance for the MEPIFORM ADHERENT SILICONE DRESSING FOR SCAR CARE. Classified as Elastomer, Silicone, For Scar Management (product code MDA), Class I - General Controls.

Submitted by Sca Molnlycke (Eddystone, US). The FDA issued a Cleared decision on March 5, 1998 after a review of 106 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4025 - 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 Sca Molnlycke devices

FDA 510(k) Submission Details - K974354

510(k) Number K974354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1997
Decision Date March 05, 1998
Days to Decision 106 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
9d faster than avg
Panel avg: 115d · This submission: 106d
Pathway characteristics
Predicate-based equivalence.

MDA Device Classification - Class 1, General Controls

Product Code MDA Elastomer, Silicone, For Scar Management
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4025
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 - MDA Elastomer, Silicone, For Scar Management

All 41
Devices cleared under the same product code (MDA) and FDA review panel - the closest regulatory comparables to K974354.
REJUVENESS
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SKAR-KARE
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K972597 · Pmt Corp. · Oct 1997