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

    ENConnect 40 mm Screw Cap to ENPlus Adapter

    K Number: K190327 · Decision Apr 9, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    87
    Registration Numbers
    87
    Same Product Code
    49
    Applicant Total
    7
    Review Days
    55

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    Basic Information

    Device Name
    ENConnect 40 mm Screw Cap to ENPlus Adapter
    K Number
    K190327
    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
    February 13, 2019
    Decision Date
    April 9, 2019
    Product Code
    PIF
    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
    PIF Gastrointestinal Tubes With Enteral Specific Connectors

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    Other Clearances by Cedic S.R.L.

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    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