510(k) Report

Devices descending from K100423

20 later devices reach Dermabond NX Adhesive Model: DNX6, DNX12 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K234114CUTIVA (TM) Topical Skin Adhesive (RM-1700); CUTIVA (TM) PLUS Skin Closure System…Okapi Medical, LLC Dba Resivant Medical20241—
+1K161050ACTABOND Topical Skin AdhesiveBergen Medical Products, Inc.20160—
+1K152476Exofin High Viscosity Tissue AdhesiveChemence Medical Products, Inc.20162—
+1K152096DERMABOND Advanced Topical Skin Adhesive, High Viscosity DERMABOND Mini Topical Skin…ETHICON, Inc.201521
+1K130329Surgiseal Topical Skin AdhesiveAdhezion Biomedical, LLC20133—
+1K130474Surgiseal Topical Skin AdhesiveAdhezion Biomedical, LLC20133—
+1K123133Barle Tissue AdhesiveAdvanced Medical Solutions (Plymouth), Ltd.20133—
+1K123936Surgiseal Topical Skin AdhesiveAdhezion Biomedical, LLC20132—
+2K243990BondEase 2 Topical Skin AdhesiveOptmed, Inc.20250—
+2K250950CUTIVA™ Topical Skin Adhesive (RM1700); CUTIVA™ PLUS Skin Closure System (RM1739)Okapi Medical, LLC Dba Resivant Medical20250—
+2K233458CM005 Standard (CM005); CM004 Mini (CM004)Connexicon Medical, Ltd.20240—
+2K200264Exofin High Viscosity Topical Skin AdhesiveChemence Medical, Inc.20201—
+2K150866SURGISEAL Topical Skin AdhesvieAdhezion Biomedical, LLC20150—
+2K133963Surgiseal Twist (TM) Topical Skin AdhesiveAdhezion Biomedical, LLC20140—
+2K141215Surgiseal Twist Topical Skin AdhesiveAdhezion Biomedical, LLC20140—
+2K140517Surgiseal Topical Skin Adhesive/Surgiseal Stylus Topical Skin AdhesiveAdhezion Biomedical, LLC20141—
+2K132243Barle Tissue Adhesive 2Advanced Medical Solutions (Plymouth), Ltd.201321
+3K212246Exofin Precision PenChemence Medical, Inc.20210—
+3K151182LiquiBand ExceedAdvanced Medical Solutions (Plymouth), Ltd.20151—
+4K183570LiquiBand PlusAdvanced Medical Solutions Limited20200—