K234114

CUTIVA(TM) Topical Skin Adhesive (RM-1700); CUTIVA(TM) PLUS Skin Closure System (RM-1739)

510(k) number
K234114
Device name
CUTIVA(TM) Topical Skin Adhesive (RM-1700); CUTIVA(TM) PLUS Skin Closure System (RM-1739)
Applicant
Okapi Medical, LLC Dba Resivant Medical OH · US
Product code
MPN — Tissue Adhesive For The Topical Approximation Of Ski
Decision date
2024-08-20
Date received
2023-12-27
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: K234114.pdf

Official FDA record: K234114
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.