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

    ZIPKNOT, MODEL 1017-3000

    K Number: K072525 · Decision Oct 5, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    110
    Registration Numbers
    110
    Same Product Code
    172
    Applicant Total
    2
    Review Days
    28

    Basic Information

    Device Name
    ZIPKNOT, MODEL 1017-3000
    K Number
    K072525
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    MEDICINELODGE, INC.
    Date Received
    September 7, 2007
    Decision Date
    October 5, 2007
    Product Code
    FZP
    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
    FZP Clip, Implantable

    Similar 510(k) Clearances

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

    Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips

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

    GEM ZIPCLIP

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

    SOLID CLIP™ Single Use Clip Applier

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

    Hem-o-lok® Ligating Clips

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

    angiOCCLUDE Ligating Clips

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

    LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic Rotating Multiple Clip Applier 10mm M/L (ER320)

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

    Other Clearances by MEDICINELODGE, INC.

    K Number Device Name
    K051488 MEDICINELODGE ZIPKNOT