510(k) Report

Devices descending from K083113

22 later devices reach Acticoat Flex 7 Dressing through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153723ACTICOAT Surgical DressingSmith & Nephew Medical Limited20160—
+1K122817Silverlon Island Wound DressingArgentum Medical, LLC201413—
+1K123961Sentrex Biosponge MPDBionova Medical, Inc.20134—
+1K103793Durafiber AGSmith & Nephew, Inc.20111—
+2K210949Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc.20223—
+2K161289DURAFIBER AgSmith & Nephew Medical Limited20160—
+2K150256Silverlon Burn Contact DressingsArgentum Medical20154—
+2K143001Silverlon Island Wound Dressing, Silverlon Wound Pad DressingArgentum Medical20145—
+2K141033Silverlon Antimicrobial Wound Contact Negative Pressure Dressings, Silverlon Easy AG…Argentum Medical, LLC20140—
+2K141573Silverlon Island Wound DressingArgentum Medical20140—
+3K231937Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc.20232—
+3K190343Silverlon Wound Contact, Burn Contact DressingsArgentum Medical, LLC20193—
+3K180570Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (also known as Silverlon…Argentum Medical, LLC20191—
+3K180533Procellera Composite Antibacterial Wound DressingVomaris Wound Care, Inc.20180—
+3K180643MedCu Antibacterial Wound Dressings with Copper-Oxide (MedCu ABWDs)Medcu Technologies, Ltd.20181—
+4K243181Foundation Dermal Regeneration Scaffold Plus (DRS+) SoloBionova Medical, Inc.20240—
+4K240298Foundation Dermal Regeneration Scaffold Plus (DRS+) DuoBionova Medical, Inc.20241—
+4K212521Field Shield Wound DressingKericure, Inc.20240—
+4K231088Copper Foam Dressing (Prescription and OTC)Roosin Medical Co., Ltd.20240—
+4K221754Ag Foam Dressing Non-Adhesive (OTC); Ag Foam Dressing Adhesive (OTC); Silicone Ag Foam…Winner Medical Co., Ltd.20230—
+4K221218Silverlon Wound Contact, Burn Contact DressingsArgentum Medical, Inc.20221—
+5K241225Silverlon® Wound Contact, Burn Contact DressingArgentum Medical, LLC20240—