K250950

CUTIVA™ Topical Skin Adhesive (RM1700); CUTIVA™ PLUS Skin Closure System (RM1739)

510(k) number
K250950
Device name
CUTIVA™ Topical Skin Adhesive (RM1700); CUTIVA™ PLUS Skin Closure System (RM1739)
Applicant
Okapi Medical, LLC Dba Resivant Medical OH · US
Product code
MPN — Tissue Adhesive For The Topical Approximation Of Ski
Decision date
2025-08-04
Date received
2025-03-28
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain

Also available from FDA: K250950.pdf

Official FDA record: K250950
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.