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

    PREPACELL THIN NEEDLE ASPIRATION TRAY

    K Number: K833719 · Decision Jan 25, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    114
    Registration Numbers
    114
    Same Product Code
    237
    Applicant Total
    11
    Review Days
    93

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    Basic Information

    Device Name
    PREPACELL THIN NEEDLE ASPIRATION TRAY
    K Number
    K833719
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Applied Medical Devices, Inc.
    Date Received
    October 24, 1983
    Decision Date
    January 25, 1984
    Product Code
    KOD
    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
    KOD Catheter, Urological

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    Other Clearances by Applied Medical Devices, Inc.

    K Number Device Name
    K843885 PERCUTANEOUS ASPIRATION BIOPSY TRAY
    K843884 GENERAL UTILITY TRAY SYSTEM
    K843883 STERILE PERCUTANEOUS TRANSHEPATIC CHOLAN
    K840904 ACCU-CULT FECAL OCCULT BLOOD TEST
    K842591 ULTRASOUND PROBE COVERS-STERILE
    K833720 TRANSTHORACIC/TRANSABDOMINAL-TRAY
    K840334 CHEMONUCLEOLYSIS/DISCOGRAPHY TRAY
    K833438 PREPACELL-STERILE-BONE MARROW ASPIR
    K802406 CYTOTRAN I BONE MARROW ASPIRATION SYSTEM
    K791660 PREPACELL-BONE MARROW SAMPLER
    Search all 11 clearances from Applied Medical Devices, Inc. →