Cleared Traditional

K864264 - TRICOTEX WOUND CONTACT LAYER DRESSING

K864264 is the FDA 510(k) clearance for TRICOTEX WOUND CONTACT LAYER DRESSING by Smith & Nephew, Inc.. It is a Class 1 General & Plastic Surgery device (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

Submission Details

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.

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 18
Devices cleared under the same product code (NAB) and FDA review panel - the closest regulatory comparables to K864264.
PRE-CUT TRACHEOSTOMY DRESSING STERILE, DISPOSABLE
K920282 · Trinity Laboratories, Inc. · May 1992
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
COVER-ROLL STRETCH
K823879 · Beiersdorf, Inc. · Mar 1983