BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇹 Italy

    Cedic Enteral ENFit Transition Connectors

    K Number: K162254 · Decision May 4, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    8
    Applicant Total
    7
    Review Days
    267

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    Basic Information

    Device Name
    Cedic Enteral ENFit Transition Connectors
    K Number
    K162254
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cedic S.R.L.
    Date Received
    August 10, 2016
    Decision Date
    May 4, 2017
    Product Code
    PIO
    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
    PIO Enteral Specific Transition Connectors

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    Other Clearances by Cedic S.R.L.

    K Number Device Name
    K181787 Cediflo Enteral Feeding Tubes & Cediflo Junior Enteral Feeding Tubes
    K190327 ENConnect 40 mm Screw Cap to ENPlus Adapter
    K150010 Cedic Oral/Luer Enteral ENFit Transition Connector for Medication Port
    K140581 CEDIC ENTERAL DISTAL END ENFIT TRANSITION CONNECTOR, CEDIC ENTERAL ENFIT TRANSITION CONNECTOR FOR MEDICATION PORT
    K072652 ENTERAL FEEDING SPIKE ADAPTER
    K042129 F00010 - IV GRAVITY SETWITH MALE LUER SLIP; F00027 - IV GRAVITY SET WITH MALE LUER LOCK