Cleared Traditional

MEPILEX (K983184) - FDA 510(k) Clearance

K983184 · Molnlycke Health Care, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1998
Decision
47d
Days
-
Risk

K983184 is an FDA 510(k) clearance for the MEPILEX. 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 October 28, 1998 after a review of 47 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.

View all Molnlycke Health Care, Inc. devices

Submission Details

510(k) Number K983184 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1998
Decision Date October 28, 1998
Days to Decision 47 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
68d faster than avg
Panel avg: 115d · This submission: 47d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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