K873669 - COMFEEL ULCUS ULCER CARE SYSTEM (FDA 510(k) Clearance)

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.

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