510(k) Report

Devices descending from K083266

12 later devices reach Gore Bio-a Fistula Plug through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162388CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas (PICS-AF)Curaseal, Inc.20170—
+1K132397Gore Bio-a Wound MatrixW. L. Gore & Associates, Inc.201410—
+2K173544Phoenix Wound MatrixNanofiber Solutions, Inc.20180—
+2K170300Restrata Wound MatrixAcera Surgical, Inc.201741
+2K161067Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen…Engineered Tissue Solutions, LLC20163—
+3K254256LUOFUCON® Wound MatrixHuizhou Foryou Medical Devices Co., Ltd.20260—
+3K260020Redermo Wound MatrixBeijing Kreate Medical Co., Ltd.20260—
+3K223725Restrata® MiniMatrixAcera Surgical, Inc.20230—
+3K222189SiOxD Wound MatrixSioxmed, LLC20222—
+3K193583Restrata®Acera Surgical, Inc.202011
+4K241660SiOxD® Wound MatrixSioxmed, LLC20240—
+4K232847SiOxD Wound MatrixSioxmed, LLC20231—