Cleared Traditional

MEPITEL NON ADHERENT SILICONE DRESSING (K984371) - FDA 510(k) Clearance

K984371 · Molnlycke Health Care, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1999
Decision
86d
Days
-
Risk

K984371 is an FDA 510(k) clearance for the MEPITEL NON ADHERENT SILICONE DRESSING. Classified as Dressing, Wound And Burn, Occlusive (product code MGP).

Submitted by Molnlycke Health Care, Inc. (Eddystone, US). The FDA issued a Cleared decision on March 3, 1999 after a review of 86 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number K984371 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1998
Decision Date March 03, 1999
Days to Decision 86 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 115d · This submission: 86d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MGP Dressing, Wound And Burn, Occlusive
Device Class -