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510(k) Data Aggregation

    K Number
    DEN000002
    Device Name
    UROSURGE PERCUTANEOUS SANS (STOLLER AFFERENT NERVE STIMULATOR) DEVICE
    Manufacturer
    UROSURGE, INC.
    Date Cleared
    2000-02-09

    (13 days)

    Product Code
    NAM
    Regulation Number
    876.5310
    Why did this record match?
    Applicant Name (Manufacturer) :

    UROSURGE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K992391
    Device Name
    UROSURGE SPIRALFLO URETERAL STENT
    Manufacturer
    UROSURGE, INC.
    Date Cleared
    1999-08-18

    (30 days)

    Product Code
    FAD
    Regulation Number
    876.4620
    Why did this record match?
    Applicant Name (Manufacturer) :

    UROSURGE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The UroSurge SpiraFlo Ureteral Stent has no holes in the walls along the side of the stent. This is in addition to the fact that it will be used for temporary drainage from the ureteropelvic junction to the bladder. Double pigtail stents have been employed to relieve obstruction in a variety of benign, malignant, and post-traumatic conditions. These stents may be placed using endoscopic, percutaneous, or even surgical techniques. These stents must not remain indwelling for more than 29 days. This product is intended for one-time use only. If the patient's status permits, the stent may be replaced with a new stent.
    Device Description
    The UroSurge SpiraFlo Ureteral Stent has no holes in the walls along the side of the stent. This is in addition to the fact that it will be used for temporary drainage from the ureteropelvic junction to the bladder. Double pigtail stents have been employed to relieve obstruction in a variety of benign, malignant, and post-traumatic conditions. These stents may be placed using endoscopic, percutaneous, or even surgical techniques. These stents must not remain indwelling for more than 29 days. This product is intended for one-time use only. If the patient's status permits, the stent may be replaced with a new stent.
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    K Number
    K981489
    Device Name
    UROSURGE SPIRASTENT PLUS URETERAL STENT
    Manufacturer
    UROSURGE, INC.
    Date Cleared
    1998-05-29

    (32 days)

    Product Code
    FAD
    Regulation Number
    876.4620
    Why did this record match?
    Applicant Name (Manufacturer) :

    UROSURGE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The UroSurge SpiraStent Plus™ Ureteral Stent, has a reinforcing filament which increases its tensile strength, thereby minimizing the probability of the stent breaking during removal. This is in addition to the fact that it will be used for temporary drainage from the ureteropelvic junction to the bladder. Double pigtail stents have been employed to relieve obstruction in a variety of benign, malignant, and post-traumatic conditions. These stents may be placed using endoscopic, percutaneous, or even surgical techniques. The duration of the placement of these stents must not remain indwelling more than twenty-nine (29) days. This product is intended for one-time use only. If the patient's status permits, the stent may be replaced with a new stent.
    Device Description
    The UroSurge SpiraStent Plus™ Ureteral Stent, has a reinforcing filament which increases its tensile strength, thereby minimizing the probability of the stent breaking during removal.
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    K Number
    K981491
    Device Name
    UROSURGE FILASTENT URETERAL STENT
    Manufacturer
    UROSURGE, INC.
    Date Cleared
    1998-05-29

    (32 days)

    Product Code
    FAD
    Regulation Number
    876.4620
    Why did this record match?
    Applicant Name (Manufacturer) :

    UROSURGE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The UroSurge FilaStent TM Ureteral Stent, has a reinforcing filament which increases its tensile strength, thereby minimizing the probability of the stent breaking during removal. This is in addition to the fact that it will be used for temporary drainage from the ureteropelvic junction to the bladder. Double pigtail stents have been employed to relieve obstruction in a variety of benign, malignant, and post-traumatic conditions. These stents may be placed using endoscopic, percutaneous, or even surgical techniques. The duration of the placement of these stents must not remain indwelling more than twenty-nine (29) days. This product is intended for one-time use only. If the patient's status permits, the stent may be replaced with a new stent.
    Device Description
    UroSurge FilaStent™ Ureteral Stent
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