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

    IRRIGATION AND ASPIRATION DEVICE FOR LAPAROSCOPIC AND OPEN SURGICAL PROCEDURES

    K Number: K933353 · Decision Feb 22, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    2
    Review Days
    228

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    Basic Information

    Device Name
    IRRIGATION AND ASPIRATION DEVICE FOR LAPAROSCOPIC AND OPEN SURGICAL PROCEDURES
    K Number
    K933353
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Utah Pioneer Medical, Inc.
    Date Received
    July 9, 1993
    Decision Date
    February 22, 1994
    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 Utah Pioneer Medical, Inc.

    K Number Device Name
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