K100261 - PRIMATRIX AG ANTIMICROBIAL DERMAL DERMAL REPAIR SCAFFOLD (FDA 510(k) Clearance)

K100261 is an FDA 510(k) clearance for the PRIMATRIX AG ANTIMICROBIAL DERMAL DERMAL REPAIR SCAFFOLD. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Tei Biosciences, Inc. (Boston, US). The FDA issued a Cleared decision on December 10, 2010 after a review of 316 days - an unusually long review period, suggesting complex equivalence evaluation.

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 Tei Biosciences, Inc. devices