Cleared Traditional

K873669 - COMFEEL ULCUS ULCER CARE SYSTEM

K873669 · Coloplast A/S · General & Plastic Surgery device
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Nov 1987
Decision
67d
Days
-
Risk

K873669 is an FDA 510(k) clearance for the COMFEEL ULCUS ULCER CARE SYSTEM. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Coloplast A/S (Fort Woth, US). The FDA issued a Cleared decision on November 17, 1987 after a review of 67 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Coloplast A/S devices

FDA 510(k) Submission Details - K873669

510(k) Number K873669 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received September 11, 1987
Decision Date November 17, 1987
Days to Decision 67 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
48d faster than avg
Panel avg: 115d · This submission: 67d
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 K873669.
FERRIS HYDROPHILIC DRESSING
K880330 · Ferris Mfg. Corp. · Mar 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
FERRIS TRANSPARENT WOUND DRESSING W/HYDROCOLLOID
K871675 · Ferris Mfg. Corp. · Aug 1987
INTRASITE INTERACTIVE HYDROCOLLOID WOUND DRESSING
K872624 · Smith & Nephew, Inc. · Jul 1987
CUTINOVA(R) PLUS FOAM GELFILM
K864913 · Beiersdorf, Inc. · Jul 1987