Cleared Special

Miro3D Fibers Wound Matrix (K240753) - FDA 510(k) Clearance

K240753 · Reprise Biomedical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2024
Decision
30d
Days
-
Risk

K240753 is an FDA 510(k) clearance for the Miro3D Fibers 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 April 19, 2024 after a review of 30 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, Inc. devices

Submission Details

510(k) Number K240753 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2024
Decision Date April 19, 2024
Days to Decision 30 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
85d faster than avg
Panel avg: 115d · This submission: 30d
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 K240753.
Cytal® Wound Matrix
K241724 · Acell, Inc. · Jul 2024
LUOFUCON® Collagen Particles (Collagen Wound Dressing)
K232796 · Huizhou Foryou Medical Devices Co., Ltd. · Apr 2024
ReyaGel (RG03 - MTP gel 3mL)
K232204 · Fettech · Apr 2024
MiroDry Wound Matrix
K240277 · Reprise Biomedical, Inc. · Mar 2024
Corplex P / Theracor P / Allacor P
K231325 · Stimlabs, LLC · Feb 2024
MiroTract Wound Matrix
K231614 · Reprise Biomedical, Inc. · Dec 2023