Cleared Special

Miro3D Wound Matrix (K223257) - FDA 510(k) Clearance

K223257 · Reprise Biomedical · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2022
Decision
31d
Days
-
Risk

K223257 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 (Plymouth, US). The FDA issued a Cleared decision on November 21, 2022 after a review of 31 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Reprise Biomedical devices

Submission Details

510(k) Number K223257 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 2022
Decision Date November 21, 2022
Days to Decision 31 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 115d · This submission: 31d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KGN Wound Dressing With Animal-derived Material(s)
Device Class -

Regulatory Consultant

DuVal & Associates, P.A.
Kathy Herzog

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KGN Wound Dressing With Animal-derived Material(s)

All 73
Devices cleared under the same product code (KGN) and FDA review panel - the closest regulatory comparables to K223257.
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