510(k) Report

Devices descending from K984210

25 later devices reach Silverlon Wound Packing Strips through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K063190Silverseal Wound Packing Strips with X-StaticNoble Fiber Technologies, Inc.20070—
+1K033587SilversealNoble Fiber Technologies20049—
+1K033869Contreet Foam Cavity Dressing with Silver, Model 9628 (2X4 in.)Coloplast Corp.200417—
+2K123961Sentrex Biosponge MPDBionova Medical, Inc.20134—
+2K100218Biatain Agfoam Dressings-Non-Adhesiv: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CMColoplast A/S201011—
+2K050726Silverseal Silveraid with X-StaticNoble Fiber Technologies, Inc.20052—
+2K050649Silverseal Contacting Wound Dressing with X-StaticNoble Fiber Technologies, Inc.20055—
+3K254246LT Antibacterial Foam with Silver DressingZhejiang Longterm Medical Technology Co., Ltd.20260—
+3K210949Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc.20223—
+3K191819Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing…Winner Medical Co., Ltd.20201—
+3K191536Biatain Silicone AgColoplast A/S20200—
+3K140954Luofucon Silver PU Antibacterial Foam DressingHuizhou Foryou Medical Devices Co., Ltd.20155—
+3K120828Biatain Silicone AG Foam Dressing - Adhesive: 3X3 Inches, 4X4 Inches, & 5X5 InchesColoplast A/S20122—
+3K083133Silveri: Coflex Afd, Coflex Afd First Aid, Afd Pad Foam Dressing, Powerflex Afd Foam…Andover Healthcare, Inc.20093—
+3K072378Prowick Antimicrobial Postoperative Wound Dressing, Shoulder and Knee, Models AR-1625…Arthrex, Inc.20071—
+4K223360LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam DressingHuizhou Foryou Medical Devices Co., Ltd.20241—
+4K223359LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam DressingHuizhou Foryou Medical Devices Co., Ltd.20230—
+4K231937Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc.20232—
+4K221754Ag Foam Dressing Non-Adhesive (OTC); Ag Foam Dressing Adhesive (OTC); Silicone Ag Foam…Winner Medical Co., Ltd.20230—
+4K160022LUOFUCON Silicone Ag foam dressingHuizhou Foryou Medical Devices Co., Ltd.20163—
+4K083007ProwickArthrex, Inc.20090—
+5K242856LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+…Huizhou Foryou Medical Devices Co., Ltd.20240—
+5K243181Foundation Dermal Regeneration Scaffold Plus (DRS+) SoloBionova Medical, Inc.20240—
+5K240298Foundation Dermal Regeneration Scaffold Plus (DRS+) DuoBionova Medical, Inc.20241—
+5K170077LUOFUCON Silicone Ag Foam Dressing with BorderHuizhou Foryou Medical Devices Co., Ltd.20172—