Cleared Traditional

K891101 - NON-ABSORBABLE GAUZE, SURGICAL SPONGE & DRESSING

K891101 is an FDA 510(k) clearance for NON-ABSORBABLE GAUZE, manufactured by Smith & Nephew United, Inc.. The device is a Class 1 General & Plastic Surgery device with product code NAB cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K891101 · Smith & Nephew United, Inc. · General & Plastic Surgery device
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Apr 1989
Decision
46d
Days
Class 1
Risk

K891101 is an FDA 510(k) clearance for the NON-ABSORBABLE GAUZE, SURGICAL SPONGE & DRESSING. Classified as Gauze / Sponge,nonresorbable For External Use (product code NAB), Class I - General Controls.

Submitted by Smith & Nephew United, Inc. (Miami, US). The FDA issued a Cleared decision on April 17, 1989 after a review of 46 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K891101

510(k) Number K891101 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received March 02, 1989
Decision Date April 17, 1989
Days to Decision 46 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 115d · This submission: 46d
Pathway characteristics
Predicate-based equivalence.

NAB Device Classification - Class 1, General Controls

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 87
Devices cleared under the same product code (NAB) and FDA review panel - the closest regulatory comparables to K891101.
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BACKGROUND SUCTION MATT
K895727 · Applied Medical Technologies, Inc. · Oct 1989
HERMITEX SPONGE
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ABSORBENT GAUZE ROLL
K890672 · Smith & Nephew United, Inc. · Apr 1989
GAUZE BANDAGE 2 X 6 YDS.
K884333 · North Health Care · Jan 1989
GAUZE BANDAGE 1 X 6 YDS.
K884334 · North Health Care · Jan 1989
K891101 · NON-ABSORBABLE GAUZE, SURGICAL SPONGE & DRESSING
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