EXCILON AMD ANTIMICROBIAL SPONGE MODEL #7088 (K011941) - FDA 510(k) Clearance

K011941 is an FDA 510(k) clearance for the EXCILON AMD ANTIMICROBIAL SPONGE MODEL #7088. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by The Kendall Company (Mansfield, US). The FDA issued a Cleared decision on August 22, 2001 after a review of 62 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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