Cleared Traditional

K840438 - COMFEEL ULCUS SHEET

K840438 · Coloplast A/S · General & Plastic Surgery device
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Nov 1984
Decision
280d
Days
-
Risk

K840438 is an FDA 510(k) clearance for the COMFEEL ULCUS SHEET. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Coloplast A/S (Fort Worth, US). The FDA issued a Cleared decision on November 7, 1984 after a review of 280 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.

View all Coloplast A/S devices

FDA 510(k) Submission Details - K840438

510(k) Number K840438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1984
Decision Date November 07, 1984
Days to Decision 280 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
165d slower than avg
Panel avg: 115d · This submission: 280d
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 263
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K840438.
BARD OCCLUSIVE WOUND DRESSING
K850889 · C.R. Bard, Inc. · Jul 1985
J & J ULCER DRESSING
K850451 · Johnson & Johnson Professionals, Inc. · Jun 1985
AQUAPHOR R GAUZE
K842967 · Beiersdorf, Inc. · Nov 1984
DUODERM FLEXIBLE HYDROACTIVE DRESSINGS
K841287 · Convatec, A Division of E.R. Squibb & Sons · Aug 1984
HYDRON WOUND DRESSING FAST SEAT KIT
K832699 · National Patent Development Corp. · Apr 1984
STERILE ABSORBENT GAUZE BURN & SOUND
K840745 · Chesebrough-Pond'S U.S.A. Co. · Apr 1984