510(k) Report

Devices descending from K050337

27 later devices reach Sis Fistula Plug through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191696Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix…Cook Biotech Incorporated20194—
+1K170016Biodesign Fistula PlugCook Biotech Incorporated20175—
+1K162388CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas (PICS-AF)Curaseal, Inc.20170—
+1K161221Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula PlugCook Biotech Incorporated20166—
+1K083266Gore Bio-a Fistula PlugW. L. Gore & Associates, Inc.200912—
+1K082682Surgisis Biodesign Enterocutaneous Fistula PlugCook Biotech, Inc.20091—
+1K082079Regen Collagen Scaffold (CS)Regen Biologics, Inc.20082—
+1K062729Surgisis RVP Recto-Vaginal Fistula PlugCook Biotech, Inc.2006012
+2K202430Kerecis ReconstructKerecis Limited20213—
+2K170364Collagen Meniscus Implant XLIvy Sports Medicine, LLC20171—
+2K162461Endoform Plastics and Reconstructive MatrixAroa Biosurgery (Formerly Mesynthes Limited)20160—
+2K150668Biodesign Enterocutaneous Fistula PlugCook Biotech Incorprated20150—
+2K132397Gore Bio-a Wound MatrixW. L. Gore & Associates, Inc.201410—
+3K251844Kerecis SurgiBind (50241)Kerecis Limited20250—
+3K251224Restrata Soft Tissue Reinforcement (STR)Acera Surgical, Inc.20250—
+3K243843Tendon Protect (50242)Kerecis Limited20250—
+3K242302RejuvaKnee™ Collagen Meniscus ImplantCollagen Matrix, Inc.20240—
+3K173544Phoenix Wound MatrixNanofiber Solutions, Inc.20180—
+3K170300Restrata Wound MatrixAcera Surgical, Inc.201741
+3K161067Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen…Engineered Tissue Solutions, LLC20163—
+4K254256LUOFUCON® Wound MatrixHuizhou Foryou Medical Devices Co., Ltd.20260—
+4K260020Redermo Wound MatrixBeijing Kreate Medical Co., Ltd.20260—
+4K223725Restrata® MiniMatrixAcera Surgical, Inc.20230—
+4K222189SiOxD Wound MatrixSioxmed, LLC20222—
+4K193583Restrata®Acera Surgical, Inc.202011
+5K241660SiOxD® Wound MatrixSioxmed, LLC20240—
+5K232847SiOxD Wound MatrixSioxmed, LLC20231—