Cleared Traditional

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

K231614 · Reprise Biomedical, Inc. · General & Plastic Surgery device
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Dec 2023
Decision
194d
Days
-
Risk

K231614 is an FDA 510(k) clearance for the MiroTract 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 December 13, 2023 after a review of 194 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Reprise Biomedical, Inc. devices

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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d slower than avg
Panel avg: 115d · This submission: 194d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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

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 K231614.
Miro3D Fibers Wound Matrix
K240753 · Reprise Biomedical, Inc. · Apr 2024
MiroDry Wound Matrix
K240277 · Reprise Biomedical, Inc. · Mar 2024
Corplex P / Theracor P / Allacor P
K231325 · Stimlabs, LLC · Feb 2024
Comatryx OTC
K232758 · Strukmyer Medical, LLC · Dec 2023
Foundation Dermal Regeneration Scaffold (DRS) Solo
K231937 · Bionova Medical, Inc. · Nov 2023
Collagen Wound Dressing
K231152 · Winner Medical Co., Ltd. · Oct 2023