BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

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

    K Number: K234114 · Decision Aug 20, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37
    Same Product Code
    35
    Applicant Total
    2
    Review Days
    237

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    Basic Information

    Device Name
    CUTIVA(TM) Topical Skin Adhesive (RM-1700); CUTIVA(TM) PLUS Skin Closure System (RM-1739)
    K Number
    K234114
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4010
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Okapi Medical, LLC Dba Resivant Medical
    Date Received
    December 27, 2023
    Decision Date
    August 20, 2024
    Product Code
    MPN
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MPN Tissue Adhesive For The Topical Approximation Of Skin

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    Other Clearances by Okapi Medical, LLC Dba Resivant Medical

    K Number Device Name
    K250950 CUTIVA™ Topical Skin Adhesive (RM1700); CUTIVA™ PLUS Skin Closure System (RM1739)