510(k) Report

Devices descending from P960052

24 later devices reach Dermabond (a Formulation of 2-Octyl Cyanoacrylate) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141157Bondease Topical Skin AdhesiveOptmed, Inc.20151—
+1K152096DERMABOND Advanced Topical Skin Adhesive, High Viscosity DERMABOND Mini Topical Skin…ETHICON, Inc.201521
+1K140517Surgiseal Topical Skin Adhesive/Surgiseal Stylus Topical Skin AdhesiveAdhezion Biomedical, LLC20141—
+1K123133Barle Tissue AdhesiveAdvanced Medical Solutions (Plymouth), Ltd.20133—
+1K121976Aesculap Histoacryl Flexible Topical Skin AdhesiveAesculap, Inc.20131—
+1K100423Dermabond NX Adhesive Model: DNX6, DNX12ETHICON, Inc.2010201
+2K243990BondEase 2 Topical Skin AdhesiveOptmed, Inc.20250—
+2K234114CUTIVA (TM) Topical Skin Adhesive (RM-1700); CUTIVA (TM) PLUS Skin Closure System…Okapi Medical, LLC Dba Resivant Medical20241—
+2K233458CM005 Standard (CM005); CM004 Mini (CM004)Connexicon Medical, Ltd.20240—
+2K161050ACTABOND Topical Skin AdhesiveBergen Medical Products, Inc.20160—
+2K152476Exofin High Viscosity Tissue AdhesiveChemence Medical Products, Inc.20162—
+2K141215Surgiseal Twist Topical Skin AdhesiveAdhezion Biomedical, LLC20140—
+2K140343Aesculap Histoacryl, Histoacryl Blue and Histoacryl Flexible Topical Skin, Adhesive with…Aesculap, Inc.20140—
+2K132243Barle Tissue Adhesive 2Advanced Medical Solutions (Plymouth), Ltd.201321
+2K130329Surgiseal Topical Skin AdhesiveAdhezion Biomedical, LLC20133—
+2K130474Surgiseal Topical Skin AdhesiveAdhezion Biomedical, LLC20133—
+2K123936Surgiseal Topical Skin AdhesiveAdhezion Biomedical, LLC20132—
+3K250950CUTIVA™ Topical Skin Adhesive (RM1700); CUTIVA™ PLUS Skin Closure System (RM1739)Okapi Medical, LLC Dba Resivant Medical20250—
+3K200264Exofin High Viscosity Topical Skin AdhesiveChemence Medical, Inc.20201—
+3K151182LiquiBand ExceedAdvanced Medical Solutions (Plymouth), Ltd.20151—
+3K150866SURGISEAL Topical Skin AdhesvieAdhezion Biomedical, LLC20150—
+3K133963Surgiseal Twist (TM) Topical Skin AdhesiveAdhezion Biomedical, LLC20140—
+4K212246Exofin Precision PenChemence Medical, Inc.20210—
+4K183570LiquiBand PlusAdvanced Medical Solutions Limited20200—