510(k) Report

Devices descending from K100029

9 later devices reach Mepilex Border AG Dressing through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223526ALLEVYN Ag+ Border Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam…Smith & Nephew Medical Limited20230—
+1K170077LUOFUCON Silicone Ag Foam Dressing with BorderHuizhou Foryou Medical Devices Co., Ltd.20172—
+1K160022LUOFUCON Silicone Ag foam dressingHuizhou Foryou Medical Devices Co., Ltd.20163—
+1K123481Aquacel AG Foam Hydrofiber Foam Dressing with Silver, Adhesive and Non AdhesiveConvatec, Inc.201301
+1K123892Mepilex Transfer AGMolnlycke Health Care20132—
+2K223360LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam DressingHuizhou Foryou Medical Devices Co., Ltd.20241—
+2K123756CovagenCovalon Technologies, Ltd.20131—
+3K242856LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+…Huizhou Foryou Medical Devices Co., Ltd.20240—
+3K192346scaffolene CL100 Bioresorbable Collagen MatrixFreudenberg Technology Innovation SE & Co. KG20200—