FDA.reportPublic FDA data

510(k) K253521

Device
ECMT-100 WMD
Applicant
Ecm Therapeutics, Inc.
510(k) number
K253521
Product code
KGN
Decision
Substantially Equivalent (SESE)
Decision date
2026-06-18
Date received
2025-11-13
Classification name
Wound Dressing With Animal-Derived Material(S)
Medical specialty
Unknown
Review panel
Unknown
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Russell Kronengold
Address
118 Marshall Dr. Warrendale PA US 15086 15086

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KGN#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260530epi-ConneKt™ Wound MatrixMLM Biologics, Inc.2026-10-15
K260652ColActive PlusCovalon Technologies, Ltd.2026-09-09
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 Biomaterials2026-08-27
K260596Collagen Wound PowderVentris Medical2026-07-02
K260669Endoform Dermal TemplateAroa Biosurgery , Ltd.2026-06-24
K253204CatalyzeBioTissue Holdings, Inc.2026-06-05
K253974Roosin Collagen DressingRoosin Medical Co., Ltd.2026-06-03
K254034Roosin Collagen PowderRoosin Medical Co., Ltd.2026-06-03
K261224MatriDermMedskin Solutions Dr. Suwelack AG2026-05-14
K260532Derma-GideGeistlich Pharma AG2026-03-19
K260218LacertaMatrixLacerta Life Sciences2026-02-19
K253140CollOvine™ Wound PowderOvigenex, LLC2026-02-10
K251323Device 104 ParticulateGeistlich Pharma AG2026-01-22
K252673LacertaMatrixLacerta Life Science2025-12-22
K253339TheracorStimlabs, LLC2025-12-22