COLLAWOUND ART (K093351) - FDA 510(k) Clearance

K093351 is an FDA 510(k) clearance for the COLLAWOUND ART. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Collamatrix, Inc. (Taipei, TW). The FDA issued a Cleared decision on June 16, 2010 after a review of 232 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Collamatrix, Inc. devices