Cleared Traditional

K925590 - MULTI-TRAUMA DRESSING

K925590 is the FDA 510(k) clearance for MULTI-TRAUMA DRESSING by Gam Industries, Inc.. It is a Class 1 General & Plastic Surgery device (product code NAB) cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K925590 · Gam Industries, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1993
Decision
154d
Days
Class 1
Risk

K925590 is an FDA 510(k) clearance for the MULTI-TRAUMA DRESSING. Classified as Gauze / Sponge,nonresorbable For External Use (product code NAB), Class I - General Controls.

Submitted by Gam Industries, Inc. (Petersburg, US). The FDA issued a Cleared decision on April 8, 1993 after a review of 154 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4014 - the FDA general and plastic surgery device framework. 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. Standard predicate reliance. 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 Gam Industries, Inc. devices

Submission Details

510(k) Number K925590 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1992
Decision Date April 08, 1993
Days to Decision 154 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
39d slower than avg
Panel avg: 115d · This submission: 154d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NAB Gauze / Sponge,nonresorbable For External Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4014
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - NAB Gauze / Sponge,nonresorbable For External Use

All 10
Devices cleared under the same product code (NAB) and FDA review panel - the closest regulatory comparables to K925590.
TRICOTEX WOUND CONTACT LAYER DRESSING
K864264 · Smith & Nephew, Inc. · Dec 1986
FEMORAL CANAL SPONGE
K831886 · Zimmer, Inc. · Sep 1983
MELOLIN
K821246 · Smith & Nephew, Inc. · Aug 1982
UNIFLEX
K820470 · Howmedica Corp. · Jun 1982
HOLLISTER ODOR ABSORBING WOUND PAD
K820464 · Hollister, Inc. · Mar 1982
TRIANGULAR BANDAGE
K811814 · Abco Dealers, Inc. · Jul 1981