K221520 - Miro3D Wound Matrix (FDA 510(k) Clearance)

K221520 is an FDA 510(k) clearance for the Miro3D Wound Matrix. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Reprise Biomedical, Inc. (Plymouth, US). The FDA issued a Cleared decision on August 18, 2022 after a review of 85 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 Reprise Biomedical, Inc. devices