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

    PREFILLED CATHETER INFLATION SYRINGE

    K Number: K112209 · Decision Sep 8, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    63
    Applicant Total
    5
    Review Days
    38

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    Basic Information

    Device Name
    PREFILLED CATHETER INFLATION SYRINGE
    K Number
    K112209
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Avail Medical Products, Inc.
    Date Received
    August 1, 2011
    Decision Date
    September 8, 2011
    Product Code
    KNY
    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
    KNY Accessories, Catheter, G-U

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    Other Clearances by Avail Medical Products, Inc.

    K Number Device Name
    K090121 PRE-FILLED CATHETER INFLATION SYRINGE
    K083189 STERI-LUB LUBRICATION GEL
    K030149 MEDTRONIC MINIMED SOF-SITE INFUSION SET, MODELS MMT-359S6, MMT-359M6, MMT-359L6, MMT-359S9, MMT-359M9, AND MMT-359L9
    K030137 MEDTRONIC MINIMED SOF-SITE INFUSION SET, MODELS MMT-358S6, MMT-358M6, MMT-358L6, MMT-358S9, MMT-358M9, AND MMT-358L9