Cleared Traditional

GILTECH PLUS TRANSPARENT DRESSING (K992005) - FDA 510(k) Clearance

K992005 · Giltech Plus, Inc. · General & Plastic Surgery device
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Sep 1999
Decision
80d
Days
-
Risk

K992005 is an FDA 510(k) clearance for the GILTECH PLUS TRANSPARENT DRESSING. Classified as Dressing, Wound And Burn, Occlusive (product code MGP).

Submitted by Giltech Plus, Inc. (Milford, US). The FDA issued a Cleared decision on September 3, 1999 after a review of 80 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 Giltech Plus, Inc. devices

Submission Details

510(k) Number K992005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1999
Decision Date September 03, 1999
Days to Decision 80 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 115d · This submission: 80d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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