Cleared Traditional

TEGAPORE WOUND CONTACT MATERIAL, PRODUCT #563X (K890354) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K890354 · 3M Company · General & Plastic Surgery device
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Apr 1989
Decision
93d
Days
Class 1
Risk

K890354 is an FDA 510(k) clearance for the TEGAPORE WOUND CONTACT MATERIAL, PRODUCT #563X. Classified as Dressing, Wound, Occlusive (product code NAD), Class I - General Controls.

Submitted by 3M Company (Cottae Grove, US). The FDA issued a Cleared decision on April 27, 1989 after a review of 93 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4020 - 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 3M Company devices

Submission Details

510(k) Number K890354 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received January 24, 1989
Decision Date April 27, 1989
Days to Decision 93 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
22d faster than avg
Panel avg: 115d · This submission: 93d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NAD Dressing, Wound, Occlusive
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4020
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 - NAD Dressing, Wound, Occlusive

All 106
Devices cleared under the same product code (NAD) and FDA review panel - the closest regulatory comparables to K890354.
3M WOUND CONTACT MATERIAL, PRODUCT #563X
K881988 · 3M Company · Jun 1988
TRANSIGEN EXUDATE CONTROLLED WOUND DRESSING
K872988 · Smith & Nephew, Inc. · Sep 1987
ALLEVYN HYDROPHILIC POLYURETHANE DRESSING
K871166 · Smith & Nephew, Inc. · Jun 1987
OPSITE WOUND DRESSING
K852211 · Smith & Nephew, Inc. · Jul 1985
HYPAFIX POST OPERATIVE DRESSING
K850282 · Smith & Nephew, Inc. · May 1985
LASTOBAND ADHESIVE BANDAGES
K831454 · Smith & Nephew, Inc. · Oct 1983