MPN — Tissue Adhesive For The Topical Approximation Of Skin Class II

FDA Device Classification

Classification Details

Product Code
MPN
Device Class
Class II
Regulation Number
878.4010
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
No

Definition

Docket number: 2006p-0071 - may 5, 2008 - reclassified from class 3 pma to class 2 510(k).

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K243990optmedBondEase 2 Topical Skin AdhesiveSeptember 19, 2025
K250950okapi medical, llc dba resivant medicalCUTIVA™ Topical Skin Adhesive (RM1700); CUTIVA™ PLUS Skin Closure System (RM1739August 4, 2025
K234114okapi medical, llc dba resivant medicalCUTIVA(TM) Topical Skin Adhesive (RM-1700); CUTIVA(TM) PLUS Skin Closure System August 20, 2024
K233458connexicon medicalCM005 Standard (CM005); CM004 Mini (CM004)July 15, 2024
K230981m/s. meril endo surgery private limitedMeriglu Topical Skin AdhesiveMarch 16, 2024
K212246chemence medicalExofin Precision PenSeptember 9, 2021
K200264chemence medicalExofin High Viscosity Topical Skin AdhesiveDecember 17, 2020
K183570advanced medical solutions limitedLiquiBand PlusMarch 9, 2020
K162352chemence medicalderma+flex QS High Viscosity Tissue AdhesiveDecember 22, 2016
K161011adhezion biomedicalSURGISEAL Topical Skin Adhesive, SURGISEAL Stylus Topical Skin Adhesive, SURGISENovember 8, 2016
K161050bergen medical productsACTABOND Topical Skin AdhesiveOctober 4, 2016
K152476chemence medical productsExofin High Viscosity Tissue AdhesiveFebruary 9, 2016
K150032glustitchGluStitch Twist Tissue AdhesiveJanuary 14, 2016
K141157optmedBONDEASE TOPICAL SKIN ADHESIVEDecember 22, 2015
K151182advanced medical solutions (plymouth)LiquiBand ExceedOctober 26, 2015
K152096ethiconDERMABOND Advanced Topical Skin Adhesive, High Viscosity DERMABOND Mini Topical October 22, 2015
K150866adhezion biomedicalSURGISEAL Topical Skin AdhesvieJuly 17, 2015
K133963adhezion biomedicalSURGISEAL TWIST (TM) TOPICAL SKIN ADHESIVESeptember 9, 2014
K141215adhezion biomedicalSURGISEAL TWIST TOPICAL SKIN ADHESIVEAugust 21, 2014
K140343aesculapAESCULAP HISTOACRYL, HISTOACRYL BLUE AND HISTOACRYL FLEXIBLE TOPICAL SKIN, ADHESMay 13, 2014