BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇲🇾 Malaysia

    SILICATH ALL SILICONE FOLEY CATHETER

    K Number: K945806 · Decision Mar 21, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    119
    Registration Numbers
    119
    Same Product Code
    127
    Applicant Total
    9
    Review Days
    113

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    Basic Information

    Device Name
    SILICATH ALL SILICONE FOLEY CATHETER
    K Number
    K945806
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Unomedical Sdn Bhd
    Date Received
    November 28, 1994
    Decision Date
    March 21, 1995
    Product Code
    EZL
    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
    EZL Catheter, Retention Type, Balloon

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    Other Clearances by Unomedical Sdn Bhd

    K Number Device Name
    K973076 EUROMEDICAL HAEMATURIA FOLEY CATHETER
    K962389 EUROMEDICAL REINFORCED ENDOTRACHEAL TUBE
    K954751 SILICONE ENDOTRACHEAL TUBE
    K954753 PEDIATRIC SILICONE ENDOTRACHEAL TUBE
    K954750 PEDIATRIC WIRE REINFORCED SILICONE ENDOTRACHEAL TUBE
    K954754 WIRE REINFORCED SILICONE ENDOTRACHEAL TUBE
    K951696 ENDOTRACHEAL TUBE
    K951697 PEDIATRIC ENDOTRACHEAL TUBE