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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tissue Adhesive For The Topical Approximation Of Skin
510(k) Number K250950
Device Name CUTIVA™ Topical Skin Adhesive (RM1700); CUTIVA™ PLUS Skin Closure System (RM1739)
Applicant
Okapi Medical, LLC Dba Resivant Medical
526 S. Main St. Suite 124m
Akron,  OH  44211
Applicant Contact Stephens Tom
Correspondent
Okapi Medical, LLC Dba Resivant Medical
526 S. Main St. Suite 124m
Akron,  OH  44211
Correspondent Contact Stephens Tom
Regulation Number878.4010
Classification Product Code
MPN  
Date Received03/28/2025
Decision Date 08/04/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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