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

    CYSTOGLIDE DILATING INTRODUCER SHEATH

    K Number: K052134 · Decision Sep 22, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    63
    Applicant Total
    6
    Review Days
    48

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    Basic Information

    Device Name
    CYSTOGLIDE DILATING INTRODUCER SHEATH
    K Number
    K052134
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Percutaneous Systems, Inc.
    Date Received
    August 5, 2005
    Decision Date
    September 22, 2005
    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 Percutaneous Systems, Inc.

    K Number Device Name
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    K042877 MICROVERTER URETERAL ACCESS SHEATH
    K040519 SLIP UROLOGY CATHETER
    K040520 SLIP UROLOGY INTRODUCER SHEATH