FDA.reportPublic FDA data

510(k) K250950

Device
CUTIVA™ Topical Skin Adhesive (RM1700); CUTIVA™ PLUS Skin Closure System (RM1739)
Applicant
Okapi Medical, LLC Dba Resivant Medical
510(k) number
K250950
Product code
MPN
Decision
Substantially Equivalent (SESE)
Decision date
2025-08-04
Date received
2025-03-28
Regulation
878.4010
Classification name
Tissue Adhesive For The Topical Approximation Of Skin
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Stephens Tom
Address
526 S. Main St. Suite 124m Akron OH US 44211 44211

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MPN#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K243990BondEase 2 Topical Skin AdhesiveOptmed, Inc.2025-09-19
K234114CUTIVA(TM) Topical Skin Adhesive (RM-1700); CUTIVA(TM) PLUS Skin Closure System (RM-1739)Okapi Medical, LLC Dba Resivant Medical2024-08-20
K233458CM005 Standard (CM005); CM004 Mini (CM004)Connexicon Medical , Ltd.2024-07-15
K230981Meriglu Topical Skin AdhesiveM/s. Meril Endo Surgery Private Limited.2024-03-16
K212246Exofin Precision PenChemence Medical, Inc.2021-09-09
K200264Exofin High Viscosity Topical Skin AdhesiveChemence Medical, Inc.2020-12-17
K183570LiquiBand PlusAdvanced Medical Solutions Limited2020-03-09
K162352derma+flex QS High Viscosity Tissue AdhesiveChemence Medical, Inc.2016-12-22
K161011SURGISEAL Topical Skin Adhesive, SURGISEAL Stylus Topical Skin Adhesive, SURGISEAL Twist Topical Skin AdhesiveAdhezion Biomedical, LLC2016-11-08
K161050ACTABOND Topical Skin AdhesiveBergen Medical Products, Inc.2016-10-04
K152476Exofin High Viscosity Tissue AdhesiveChemence Medical Products, Inc.2016-02-09
K150032GluStitch Twist Tissue AdhesiveGlustitch, Inc.2016-01-14
K141157BONDEASE TOPICAL SKIN ADHESIVEOptmed, Inc.2015-12-22
K151182LiquiBand ExceedAdvanced Medical Solutions (Plymouth), Ltd.2015-10-26
K152096DERMABOND Advanced Topical Skin Adhesive, High Viscosity DERMABOND Mini Topical Skin AdhesiveETHICON, Inc.2015-10-22