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510(k) Data Aggregation

    K Number
    K063079
    Device Name
    I-STOP TRANS OBTURATOR MALE SLING
    Manufacturer
    CL MEDICAL
    Date Cleared
    2006-11-07

    (28 days)

    Product Code
    OTM, FTL
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    CL MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    I-STOP® Trans Obturator Male / Female Sling is intended to be used as a sub-urethral sling implant for the treatment of male stress urinary incontinence post-prostatectomy. And for females: for the treatment of urinary stress incontinence due to intrinsic sphincter deficiency and/or intrinsic sphincter deficiency.
    Device Description
    I-STOP® Trans Obturator Male / Female Sling is a sterile, single use kit consisting of one sling of knitted monofilament polypropylene, two stainless two polycarbonate handles and two stainless steel needles molded with polycarbonate handles.
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    K Number
    K051533
    Device Name
    I-STOP
    Manufacturer
    CL MEDICAL
    Date Cleared
    2005-08-11

    (63 days)

    Product Code
    OTN
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    CL MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    I-STOP® is intended to be used as a pubo-urethral sling for the treatment of female urinary incontinence.
    Device Description
    I-STOP is a sterile, single use kit consisting of knitted monofilament polypropylene, two to four stainless steel needles and two polycarbonate handles. The kit is designed to be used with any of the surgical approaches to position the sling.
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