510(k) Report

Devices descending from K132397

10 later devices reach Gore Bio-a Wound Matrix through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173544Phoenix Wound MatrixNanofiber Solutions, Inc.20180—
+1K170300Restrata Wound MatrixAcera Surgical, Inc.201741
+1K161067Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen…Engineered Tissue Solutions, LLC20163—
+2K254256LUOFUCON® Wound MatrixHuizhou Foryou Medical Devices Co., Ltd.20260—
+2K260020Redermo Wound MatrixBeijing Kreate Medical Co., Ltd.20260—
+2K223725Restrata® MiniMatrixAcera Surgical, Inc.20230—
+2K222189SiOxD Wound MatrixSioxmed, LLC20222—
+2K193583Restrata®Acera Surgical, Inc.202011
+3K241660SiOxD® Wound MatrixSioxmed, LLC20240—
+3K232847SiOxD Wound MatrixSioxmed, LLC20231—