Cleared Traditional

ABSORBENT PAD -- MODIFICATION (K923602) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K923602 · Winfield Laboratories, Inc. · General & Plastic Surgery device
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Dec 1992
Decision
145d
Days
Class 1
Risk

K923602 is an FDA 510(k) clearance for the ABSORBENT PAD -- MODIFICATION. Classified as Gauze / Sponge,nonresorbable For External Use (product code NAB), Class I - General Controls.

Submitted by Winfield Laboratories, Inc. (Richardson, US). The FDA issued a Cleared decision on December 7, 1992 after a review of 145 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 Winfield Laboratories, Inc. devices

Submission Details

510(k) Number K923602 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1992
Decision Date December 07, 1992
Days to Decision 145 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 115d · This submission: 145d
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

Devices cleared under the same product code (NAB) and FDA review panel - the closest regulatory comparables to K923602.
TRICOTEX WOUND CONTACT LAYER DRESSING
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UNIFLEX
K820470 · Howmedica Corp. · Jun 1982
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BANDAGE COMPRESS 2, 3, 4
K770410 · Johnson & Johnson Professionals, Inc. · Jun 1977