510(k) Report

Devices descending from K061554

14 later devices reach Mepilex AG Absorbent Silicone-Coated Dressing through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100029Mepilex Border AG DressingMolnlycke Health Care20109—
+1K083133Silveri: Coflex Afd, Coflex Afd First Aid, Afd Pad Foam Dressing, Powerflex Afd Foam…Andover Healthcare, Inc.20093—
+1K091013Silver PU Antibacterial Foam Dressing - Non Adherent and IslandAdvanced Medical Solutions Limited20090—
+1K071354Mepilex AG DressingMonlycke Health Care20071—
+2K223360LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam DressingHuizhou Foryou Medical Devices Co., Ltd.20241—
+2K223359LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam DressingHuizhou Foryou Medical Devices Co., Ltd.20230—
+2K223526ALLEVYN Ag+ Border Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam…Smith & Nephew Medical Limited20230—
+2K170077LUOFUCON Silicone Ag Foam Dressing with BorderHuizhou Foryou Medical Devices Co., Ltd.20172—
+2K160022LUOFUCON Silicone Ag foam dressingHuizhou Foryou Medical Devices Co., Ltd.20163—
+2K123481Aquacel AG Foam Hydrofiber Foam Dressing with Silver, Adhesive and Non AdhesiveConvatec, Inc.201301
+2K123892Mepilex Transfer AGMolnlycke Health Care20132—
+3K242856LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+…Huizhou Foryou Medical Devices Co., Ltd.20240—
+3K123756CovagenCovalon Technologies, Ltd.20131—
+4K192346scaffolene CL100 Bioresorbable Collagen MatrixFreudenberg Technology Innovation SE & Co. KG20200—