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

    PC-204 TUNNELOR

    K Number: K823331 · Decision Jan 26, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    82
    Applicant Total
    9
    Review Days
    79

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    Basic Information

    Device Name
    PC-204 TUNNELOR
    K Number
    K823331
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5630
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Medigroup
    Date Received
    November 8, 1982
    Decision Date
    January 26, 1983
    Product Code
    FKX
    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
    FKX System, Peritoneal, Automatic Delivery

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    Other Clearances by Medigroup

    K Number Device Name
    K823294 MEDIGROUP LS-110 LIGHT SOURCE
    K823297 ST-610 NEEDLESCOPE STERILIZATION TRAY
    K823295 MEDIGROUP 2.2MM NEEDLESCOPE CANNULA&
    K823293 MEDIGROUP LG-102 LIGHT GUIDE
    K823296 PC-205 TENCKHOFF CATHETER ROD OBTURATOR
    K823330 DIALATORS PC-203 & 202
    K823303 QUILL CATHETER GUIDE
    K823390 PC 201A LOCKING SLEEVE