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

    SUPERSTITCH

    K Number: K994087 · Decision Mar 1, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52
    Same Product Code
    69
    Applicant Total
    5
    Review Days
    89

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    Basic Information

    Device Name
    SUPERSTITCH
    K Number
    K994087
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sutura, Inc.
    Date Received
    December 3, 1999
    Decision Date
    March 1, 2000
    Product Code
    OCW
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    OCW Endoscopic Tissue Approximation Device

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    Other Clearances by Sutura, Inc.

    K Number Device Name
    K062125 SUPERSTITCH 5F, 12F, AND EL
    K053482 SUPERSTITCH GW, MODELS 06-15-04-GW, 08-15-04-GW
    K020940 SUPERSTITCH VASCULAR SUTURING DEVICE, 6 FRENCH, MODELS 06-15-00X; MID-LENGTH 06-25-00X
    K012865 SUPERSTITCH VASCULAR SUTURING DEVICE