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510(k) K213573

Device
PELNAC Wound Matrix
Applicant
Gunze Limited
510(k) number
K213573
Product code
KGN  
Decision
Substantially Equivalent (SESE)
Decision date
2022-02-09
Date received
2021-11-10
Regulation
510(k) Premarket Notification
Classification name
Dressing, Wound, Collagen
Medical specialty
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
Review panel
General & Plastic Surgery
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Hidenori Nishioka
Address
46 Natsumegaichi, Aono Ayabe, Kyoto JP 623-8513 623-8513

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
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
K253521ECMT-100 WMDEcm Therapeutics, Inc.2026-06-18
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
K250864MatriDerm pluS+ Bi-LayerMedskin Solutions Dr. Suwelack AG2025-12-19

Legacy Summary#

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FDA Review#

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