BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    SilverCoat Silicone Foley Catheter

    K Number: K150550 · Decision Nov 24, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    119
    Registration Numbers
    119
    Same Product Code
    127
    Applicant Total
    6
    Review Days
    266

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    Basic Information

    Device Name
    SilverCoat Silicone Foley Catheter
    K Number
    K150550
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Covalontechnologies, Inc.
    Date Received
    March 3, 2015
    Decision Date
    November 24, 2015
    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 Covalontechnologies, Inc.

    K Number Device Name
    K163556 MediClear PreOp
    K121819 SURGICLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER
    K112549 IV CLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER
    K043296 COLACTIVE AG COLLAGEN WITH SILVER ANTIMICROBIAL DRESSING
    K050177 COLACTIVE COLLAGEN WOUND DRESSING