Cleared Traditional

K904411 - INTRASITE GEL (LABELING REVISION)

K904411 is the FDA 510(k) clearance for INTRASITE GEL (LABELING REVISION) by Smith & Nephew United, Inc.. It is a Class 1 General & Plastic Surgery device (product code KMF) cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K904411 · Smith & Nephew United, Inc. · General & Plastic Surgery device
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Nov 1990
Decision
61d
Days
Class 1
Risk

K904411 is an FDA 510(k) clearance for the INTRASITE GEL (LABELING REVISION). Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Smith & Nephew United, Inc. (Largo, US). The FDA issued a Cleared decision on November 26, 1990 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 880.5090 - 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 United, Inc. devices

Submission Details

510(k) Number K904411 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received September 26, 1990
Decision Date November 26, 1990
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 KMF Bandage, Liquid
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5090
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 - KMF Bandage, Liquid

All 68
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K904411.
BRND SKIN PROTECTION PREP SERIES 33XX
K920794 · 3M Health Care, Ltd. · Aug 1992
COMFEEL CONTOUR DRESSING
K920925 · Coloplast A/S · May 1992
ALLEVLYN WOUND DRESSING, MODIFICATION
K914147 · Smith & Nephew United, Inc. · Feb 1992
ALLEVYN DRESSING (LABELING REVISED)
K901877 · Smith & Nephew United, Inc. · Jun 1990
INTRASITE GEL (LABELING REVISION)
K901878 · Smith & Nephew United, Inc. · Jun 1990
DUODERM* CONTROL GEL FORMULA BORDER DRESSING
K901155 · Convatec, A Division of E.R. Squibb & Sons · Apr 1990