510(k) Report

Devices descending from K022127

28 later devices reach Avagen Wound Dressing through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241904DermiSphere Dermal TemplateFesariustherapeutics, Inc.20250—
+1K213573PELNAC Wound MatrixGunze Limited20220—
+1K210128INTEGRA Wound Matrix (Macro-Channels)Integra LifeSciences Corporation20210—
+1K191992PELNAC Bilayer Wound MatrixGunze Limited20200—
+1K140456Bio-Connekt Wound MatrixMLM Biologics, Inc.20140—
+1K132397Gore Bio-a Wound MatrixW. L. Gore & Associates, Inc.201410—
+1K130557Neuragen 3DIntegra LifeSciences Corporation20141—
+1K113104Integra Wound Matrix (Thin)Integra LifeSciences Corporation20120—
+1K090894Collawound Wound DressingCollamatrix Co., Inc.20092—
+1K072113Integra Flowable Wound Matrix, Model FWD301Integra Lifesciences Corp.200751
+2K250329GeniPhys Collymer Self-Assembling ScaffoldGeniphys, Inc.20250—
+2K173544Phoenix Wound MatrixNanofiber Solutions, Inc.20180—
+2K162348ABCcolla Collagen MatrixAcro Biomedical Co., Ltd.20171—
+2K170300Restrata Wound MatrixAcera Surgical, Inc.201741
+2K163457NeuraGen 3D Nerve Guide MatrixIntegra LifeSciences Corporation20170—
+2K161067Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen…Engineered Tissue Solutions, LLC20163—
+2K134037PremviaBiotime, Inc.20140—
+2K110318ExcellagenTissue Repair Company20110—
+2K102946Coreleader Colla-Pad Model CS 03030Coreleader Biotech Co., Ltd.20110—
+2K081724Hydrolyzed Collagen with 10% Chondroitin Sulfate (Psgag, Polysulfated Glycosaminoglycan)…Applied Nutritionals20080—
+3K254256LUOFUCON® Wound MatrixHuizhou Foryou Medical Devices Co., Ltd.20260—
+3K260020Redermo Wound MatrixBeijing Kreate Medical Co., Ltd.20260—
+3K233378ABCcolla® Collagen ADM ScaffoldAcro Biomedical Co., Ltd.20240—
+3K223725Restrata® MiniMatrixAcera Surgical, Inc.20230—
+3K222189SiOxD Wound MatrixSioxmed, LLC20222—
+3K193583Restrata®Acera Surgical, Inc.202011
+4K241660SiOxD® Wound MatrixSioxmed, LLC20240—
+4K232847SiOxD Wound MatrixSioxmed, LLC20231—