Cleared Traditional

K864264 - TRICOTEX WOUND CONTACT LAYER DRESSING

K864264 is an FDA 510(k) clearance for TRICOTEX WOUND CONTACT LAYER DRESSING, manufactured by Smith & Nephew, Inc.. The device is a Class 1 General & Plastic Surgery device with product code NAB cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K864264 · Smith & Nephew, Inc. · General & Plastic Surgery device
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Dec 1986
Decision
61d
Days
Class 1
Risk

K864264 is an FDA 510(k) clearance for the TRICOTEX WOUND CONTACT LAYER DRESSING. Classified as Gauze / Sponge,nonresorbable For External Use (product code NAB), Class I - General Controls.

Submitted by Smith & Nephew, Inc. (Massillon, US). The FDA issued a Cleared decision on December 29, 1986 after a review of 61 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.

View all Smith & Nephew, Inc. devices

FDA 510(k) Submission Details - K864264

510(k) Number K864264 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received October 29, 1986
Decision Date December 29, 1986
Days to Decision 61 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
54d faster than avg
Panel avg: 115d · This submission: 61d
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 33
Devices cleared under the same product code (NAB) and FDA review panel - the closest regulatory comparables to K864264.
POST OPERATIVE SPONGE
K912693 · Ulti-Med Intl., Inc. · Oct 1991
NON-ABSORBABLE GAUZE, SURGICAL SPONGE & DRESSING
K891101 · Smith & Nephew United, Inc. · Apr 1989
ABSORBENT GAUZE ROLL
K890672 · Smith & Nephew United, Inc. · Apr 1989
AN ODOR ABSORBENT BANDAGE
K833735 · American Medical Disposable, Inc. · Apr 1984
FEMORAL CANAL SPONGE
K831886 · Zimmer, Inc. · Sep 1983
NOVA GAUZE
K830473 · American Threshold Industries, Inc. · Apr 1983