Cleared Traditional

K890354 - TEGAPORE WOUND CONTACT MATERIAL, PRODUCT #563X

K890354 is an FDA 510(k) clearance for TEGAPORE WOUND CONTACT MATERIAL, manufactured by 3M Company. The device is a Class 1 General & Plastic Surgery device with product code NAD cleared through the Traditional 510(k) pathway after a 93-day FDA review.

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

FDA 510(k) Submission Details - K890354

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.

NAD Device Classification - Class 1, General Controls

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 50
Devices cleared under the same product code (NAD) and FDA review panel - the closest regulatory comparables to K890354.
HYPAFIX DRESSING RETENTION SHEET
K894254 · Smith & Nephew United, Inc. · Aug 1989
DUODERM* TRANSPARENT HYDROCOLLOID DRESSING-MODIFY
K892527 · Convatec, A Division of E.R. Squibb & Sons · May 1989
DUODERM* EXTRA THIN FLEXIBLE HYDROCOLLOID DRESSING
K891696 · Convatec, A Division of E.R. Squibb & Sons · May 1989
POLYMER ADHESIVE BANDAGE
K883391 · Marion Laboratories, Inc. · Mar 1989
ALLEVYN TRACHEOSTOMY DRESSING
K890748 · Smith & Nephew United, Inc. · Mar 1989
TECNOL VARIABLE TENSION BANDAGE
K884440 · Tecnol New Jersey Wound Care, Inc. · Jan 1989