Cleared Traditional

K912953 - GAUZE COMPRESS

K912953 is the FDA 510(k) clearance for GAUZE COMPRESS by Cal West Trading Co.. It is a Class 1 General & Plastic Surgery device (product code NAB) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K912953 · Cal West Trading Co. · General & Plastic Surgery device
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Sep 1991
Decision
90d
Days
Class 1
Risk

K912953 is an FDA 510(k) clearance for the GAUZE COMPRESS. Classified as Gauze / Sponge,nonresorbable For External Use (product code NAB), Class I - General Controls.

Submitted by Cal West Trading Co. (Santa Fe Springs, US). The FDA issued a Cleared decision on September 30, 1991 after a review of 90 days - within the typical 510(k) review window.

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 Cal West Trading Co. devices

Submission Details

510(k) Number K912953 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 1991
Decision Date September 30, 1991
Days to Decision 90 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
25d faster than avg
Panel avg: 115d · This submission: 90d
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 K912953.
TRICOTEX WOUND CONTACT LAYER DRESSING
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FEMORAL CANAL SPONGE
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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