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

    CURVILINEAR SUTURE PLACEMENT SYSTEM

    K Number: K973415 · Decision Dec 2, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    4
    Review Days
    84

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    Basic Information

    Device Name
    CURVILINEAR SUTURE PLACEMENT SYSTEM
    K Number
    K973415
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Laurus Medical Corp.
    Date Received
    September 9, 1997
    Decision Date
    December 2, 1997
    Product Code
    GCJ
    Advisory Committee
    Gastroenterology, Urology
    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
    GCJ Laparoscope, General & Plastic Surgery

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    Other Clearances by Laurus Medical Corp.

    K Number Device Name
    K973215 STEREOTACTIC NEEDLE CORE BIOPSY SYSTEM
    K960317 LAURUS NEEDLE CORE BIOPSY SYSTEM
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