Cleared Traditional

K231614 - MiroTract Wound Matrix (FDA 510(k) Clearance)

K231614 · Reprise Biomedical, Inc. · General & Plastic Surgery device

Dec 2023

Decision

194d

Days

Risk

K231614 is an FDA 510(k) clearance for the MiroTract 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 December 13, 2023, 194 days after receiving the submission on June 2, 2023.

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

Submission Details

510(k) Number	K231614 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 02, 2023
Decision Date	December 13, 2023
Days to Decision	194 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF