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FDA 510(k)

epi-ConneKt™ Wound Matrix

K-Number: K260530 · 2026-10-15

ApplicantMLM Biologics, Inc.
Decision Date2026-10-15
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

epi-ConneKt™ Wound Matrix is the device name listed in this FDA 510(k) record. The listed applicant is MLM Biologics, Inc.. It received FDA 510(k) clearance on 2026-10-15 under 510(k) number K260530. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the epi-ConneKt™ Wound Matrix?

epi-ConneKt™ Wound Matrix is a medical device that received FDA 510(k) clearance on 2026-10-15. The listed applicant is MLM Biologics, Inc.. The 510(k) number is K260530.

When did epi-ConneKt™ Wound Matrix receive FDA 510(k) clearance?

epi-ConneKt™ Wound Matrix received FDA 510(k) clearance on 2026-10-15, under 510(k) number K260530.

Who is the listed applicant for epi-ConneKt™ Wound Matrix?

The FDA 510(k) record lists MLM Biologics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for epi-ConneKt™ Wound Matrix?

The FDA product code for epi-ConneKt™ Wound Matrix is KGN.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT04745156A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade GliomasNOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED

Related Devices (Code: KGN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260652ColActive PlusCovalon Technologies, Ltd.K260711Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc (CG-03AP);Accelagen Plus Surgical Matrix, 5cc (CG-05AP);Accelagen Plus Surgical Strip, 125x25x2mm (CG-125X25AP);Accelagen Plus Surgical Strip, 250x25x2mm (CG-250X25AP)Berkeley Advanced BiomaterialsK260596Collagen Wound PowderVentris MedicalK260669Endoform Dermal TemplateAroa Biosurgery , Ltd.K253521ECMT-100 WMDEcm Therapeutics, Inc.K253204CatalyzeBioTissue Holdings, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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