Cleared Traditional

K872298 - TEGASORB ULCER DRESSING #90-XXX

K872298 · 3M Company · General & Plastic Surgery device
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Apr 1988
Decision
291d
Days
-
Risk

K872298 is an FDA 510(k) clearance for the TEGASORB ULCER DRESSING #90-XXX. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by 3M Company (Cottae Grove, US). The FDA issued a Cleared decision on April 1, 1988 after a review of 291 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel. 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.

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Submission Details

510(k) Number K872298 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received June 15, 1987
Decision Date April 01, 1988
Days to Decision 291 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
176d slower than avg
Panel avg: 115d · This submission: 291d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 221
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K872298.
COMPEED ATHLETIC DRESSING
K883588 · Coloplast A/S · Sep 1988
HYDROCOLLOID DRESSING FOR PSORIASIS
K881039 · Hollister, Inc. · Jun 1988
DUODERM(R) HYDROACTIVE(R) PASTE
K881302 · Convatec, A Division of E.R. Squibb & Sons · Apr 1988
AIRSTRIP* WATERPROOF FIRST AID DRESS/POST-OPERA.
K881048 · Smith & Nephew, Inc. · Mar 1988
DERMATOLOGICAL PATCH
K872926 · Convatec, A Division of E.R. Squibb & Sons · Feb 1988
COMFEEL ULCUS ULCER CARE SYSTEM
K873669 · Coloplast A/S · Nov 1987