COLLAWOUND DRESSING (K061474) - FDA 510(k) Clearance

K061474 is an FDA 510(k) clearance for the COLLAWOUND DRESSING. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Collamatrix Co., Inc. (Taipei, TW). The FDA issued a Cleared decision on July 5, 2006 after a review of 36 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 Collamatrix Co., Inc. devices