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

    Exofin High Viscosity Tissue Adhesive

    K Number: K152476 · Decision Feb 9, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37
    Same Product Code
    35
    Applicant Total
    2
    Review Days
    162

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Exofin High Viscosity Tissue Adhesive
    K Number
    K152476
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    878.4010
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Chemence Medical Products, Inc.
    Date Received
    August 31, 2015
    Decision Date
    February 9, 2016
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (MPN), ordered by most recent decision date.

    BondEase 2 Topical Skin Adhesive

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

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

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

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

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    CM005 Standard (CM005); CM004 Mini (CM004)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Meriglu Topical Skin Adhesive

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Exofin Precision Pen

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all

    Other Clearances by Chemence Medical Products, Inc.

    K Number Device Name
    K101276 DERMA+FLEX QS HIGH VISCOSITY TISSUE ADHESIVE MODEL: QS70404