Cleared Traditional

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

K221520 · Reprise Biomedical, Inc. · General & Plastic Surgery device

Aug 2022

Decision

85d

Days

Risk

K221520 is an FDA 510(k) clearance for the Miro3D Wound Matrix. This device is classified as a Wound Dressing With Animal-derived Material(s).

Submitted by Reprise Biomedical, Inc. (Plymouth, US). The FDA issued a Cleared decision on August 18, 2022, 85 days after receiving the submission on May 25, 2022.

This device falls under the General & Plastic Surgery FDA review panel.

Submission Details

510(k) Number	K221520 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 25, 2022
Decision Date	August 18, 2022
Days to Decision	85 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF