Cleared Traditional

K990079 - FASTSEAL CHEST WOUND DRESSING

K990079 · Greenfield Medical Technologies, Inc. · General & Plastic Surgery device
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Dec 1999
Decision
346d
Days
-
Risk

K990079 is an FDA 510(k) clearance for the FASTSEAL CHEST WOUND DRESSING. Classified as Dressing, Wound And Burn, Occlusive (product code MGP).

Submitted by Greenfield Medical Technologies, Inc. (Northborough, US). The FDA issued a Cleared decision on December 23, 1999 after a review of 346 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Greenfield Medical Technologies, Inc. devices

FDA 510(k) Submission Details - K990079

510(k) Number K990079 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1999
Decision Date December 23, 1999
Days to Decision 346 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
231d slower than avg
Panel avg: 115d · This submission: 346d
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 57
Devices cleared under the same product code (MGP) and FDA review panel - the closest regulatory comparables to K990079.
SIMPLICARE TRANSPARENT WOUND DRESSING
K991214 · Hollister, Inc. · Oct 1999
DERMAPHYLYX SKIN PROTECTORS, PROTECT IT SKIN PROTECTORS
K992302 · Dermaphylyx, Inc. · Sep 1999
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
MEPITEL NON ADHERENT SILICONE DRESSING
K984371 · Molnlycke Health Care, Inc. · Mar 1999