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    K Number
    K120127
    Device Name
    SWAN VALLEY MEDICAL TRANURETHRAL SUPRAPUBIC ENDO-CYSTOSTOMY (T-SPEC) SURGICAL SYSTEM
    Manufacturer
    SWAN VALLEY MEDICAL, INCORPORATED
    Date Cleared
    2012-10-26

    (283 days)

    Product Code
    KOB, FEX
    Regulation Number
    876.5090
    Why did this record match?
    Applicant Name (Manufacturer) :

    SWAN VALLEY MEDICAL, INCORPORATED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Swan Valley Medical Transurethral Suprapubic endo-Cystostomy (T-SPeC®) Surgical System is intended for suprapubic bladder catheterization (cystostomy) and drainage. The catheter should not be allowed to remain indwelling for more than 29 days.
    Device Description
    The T-SPeCTM Surgical System is, in effect, a sterile suprapubic catheter and accessory kit consisting of a) a suprapubic catheter; b) a catheter punch instrument used to create a cystostomy and place the suprapubic catheter; and c) a piston syringe to fill the catheter balloon after placement.
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