Cleared Traditional

K891288 - TEGASORB(TM) ULCER DRESSING, #90-XXX

K891288 · 3M Company · General & Plastic Surgery device
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Jun 1989
Decision
91d
Days
-
Risk

K891288 is an FDA 510(k) clearance for the TEGASORB(TM) 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 June 9, 1989 after a review of 91 days - within the typical 510(k) review window.

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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FDA 510(k) Submission Details - K891288

510(k) Number K891288 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received March 10, 1989
Decision Date June 09, 1989
Days to Decision 91 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
24d faster than avg
Panel avg: 115d · This submission: 91d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 500
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K891288.
KALTOSTAT WOUND PACKING
K892868 · Calgon Vestal Div. · Jul 1989
KALTOSTAT(TM) WOUND DRESSING
K892364 · Calgon Vestal Div. · Jun 1989
CUTINOVA(R) PLUS ON VASCULAR STASIS ULCERS
K885279 · Beiersdorf, Inc. · Jun 1989
WATER JEL STERILE GEL-SOAKED BURN DRESSING
K892360 · Pfizer, Inc. · Jun 1989
ACTIDERM*-OPAQUE
K892232 · Convatec, A Division of E.R. Squibb & Sons · May 1989
PHARMACLENS LOW ABRASION WOUND SPONGE/BRUSH
K885045 · Baxter Healthcare Corp · Mar 1989