FDA 510(k)

ECMT-100 WMD

K-Number: K253521 · 2026-06-18

Decision Date2026-06-18

Product CodeKGN

DecisionSubstantially Equivalent

Device Summary

ECMT-100 WMD is the device name listed in this FDA 510(k) record. The listed applicant is Ecm Therapeutics, Inc.. It received FDA 510(k) clearance on 2026-06-18 under 510(k) number K253521. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ECMT-100 WMD?

ECMT-100 WMD is a medical device that received FDA 510(k) clearance on 2026-06-18. The listed applicant is Ecm Therapeutics, Inc.. The 510(k) number is K253521.

When did ECMT-100 WMD receive FDA 510(k) clearance?

ECMT-100 WMD received FDA 510(k) clearance on 2026-06-18, under 510(k) number K253521.

Who is the listed applicant for ECMT-100 WMD?

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

What is the FDA product code for ECMT-100 WMD?

The FDA product code for ECMT-100 WMD is KGN.

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.

K260596Collagen Wound PowderVentris Medical K260669Endoform Dermal TemplateAroa Biosurgery , Ltd.K253204CatalyzeBioTissue Holdings, Inc.K254034Roosin Collagen PowderRoosin Medical Co., Ltd.K253974Roosin Collagen DressingRoosin Medical Co., Ltd.K261224MatriDermMedskin Solutions Dr. Suwelack AG

Official Source

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