Cleared Traditional

K984371 - MEPITEL NON ADHERENT SILICONE DRESSING

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.

View all Molnlycke Health Care, Inc. devices

FDA 510(k) Submission Details - K984371

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 115d · This submission: 86d
Pathway characteristics
Predicate-based equivalence.

MGP Device Classification - Class 0,

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

Regulatory Peers - MGP Dressing, Wound And Burn, Occlusive

All 60
Devices cleared under the same product code (MGP) and FDA review panel - the closest regulatory comparables to K984371.
GILTECH PLUS TRANSPARENT DRESSING
K992005 · Giltech Plus, Inc. · Sep 1999
DERMAPHYLYX FILM WOUND DRESSING AND HEALIAN FILM WOUND DRESSING
K990875 · Dermaphylyx, Inc. · May 1999
DERMAFLEX WOUND DRESSING, DERMAFLEX FOAM WOUND DRESSING, HEALIAFLEX WOUND DRESSING, HEALIAFOAM WOUND DRESSING
K990438 · Dermaphylyx, Inc. · Mar 1999
INNOVATIVE TECHNOLOGIES HYDROCOLLOID AND INTELLIGENT HYDROCOLLOID WOUND DRESSINGS
K983303 · Innovative Technologies , Ltd. · Dec 1998
TIELLE PLUS HYDROPOLYMER ADHESIVE DRESSING
K983234 · Johnson & Johnson Medical, Div. of Ethicon, Inc. · Nov 1998
MODIFICATION TO TIELLE HYDROPOLMER DRESSING
K983394 · Johnson & Johnson Medical, Div. of Ethicon, Inc. · Nov 1998