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510(k) Data Aggregation

    K Number
    K041732
    Device Name
    CAVERMAP SURGICAL AID
    Manufacturer
    BLUE TORCH MEDICAL TECHNOLOGIES
    Date Cleared
    2004-09-21

    (88 days)

    Product Code
    FGM
    Regulation Number
    876.4730
    Why did this record match?
    Product Code :

    FGM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Blue Torch Medical Technologies CaverMap® Surgical Aid Perineal Tip is an accessory stimulating tip to be used for a perineal approach to nerve stimulation. It is an addition to the Blue Torch Medical Technologies CaverMap® Surgical Aid System. The system is indicated for use in the stimulation of the cavemosal and associated parasympathetic nerves during open or laproscopic prostatectorny, prostate brachytherapy placement, prostate cryotherapy, and open colorectal (surgical) procedures in males. The device aids the physician in locating these nerves. The device is designed as an adjunct to the current open or laproscopic prostatectomy, prostate brachytherapy placement, prostate cryotherapy, and open colorectal procedures in which a nerve sparing technique is used. The Surgical Aid is not designed to replace the surgeon's expertise in mapping out the neurovascular bundles. Each physician's skill determines whether these nerves are spared regardless of any aid.
    Device Description
    The CaverMap Surgical Aid Perineal Tip has been designed specifically for use during perineal radical prostatectomy, prostate brachytherapy, and prostate cryotherapy procedures, where a nerve sparing technique is employed. The perineal probe tip is designed as a single electrode made from surgical stainless steel. The probe tip is encapsulated in dielectrical insulating tubing, with the exception of the tip which is exposed to deliver the stimulation to the nerves. The tip also includes graduated length markings below the insulating tubing. The surface area of the stimulating (exposed) trocar tip is the same as the current electrodes of the currently marketed probe tip, giving the electrode the same charge density profile as the currently marketed probe tips. A new reusable control handle was also designed in order to allow for a proper connection to the new probe tip. The materials used to manufacture the new handle are exactly the same as the currently marketed product. The perineal probe tip functions exactly the same as the existing probe tip. The new tip was designed for use during nerve sparing procedures where a perineal approach to stimulating the cavernosal nerves is indicated.
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    K Number
    K031527
    Device Name
    MODIFICATION TO CAVERMAP SURGICAL AID
    Manufacturer
    BLUE TORCH MEDICAL TECHNOLOGIES
    Date Cleared
    2003-06-05

    (21 days)

    Product Code
    FGM
    Regulation Number
    876.4730
    Why did this record match?
    Product Code :

    FGM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Blue Torch Medical Technologies CaverMap® Surgical Aid Video Monitor is a modification to the Blue Torch Medical Technologies CaverMap® Surgical Aid System is indicated for use in the stimulation of the cavernosal and associated parasympathetic nerves during open or laproscopic prostatectomy and open colorectal (surgical) procedures in males. The device aids the surgeon in locating these nerves. The device is designed as an adjunct to the current open or laproscopic prostatectomy and open colorectal procedures in which a nerve sparing technique is used. The Surgical Aid is not designed to replace the surgeon's expertise in mapping out the neurovascular bundles. Each surgeon's skill determines whether these nerves are spared regardless of any aid..
    Device Description
    The CaverMap Surgical Aid Monitor consists of a self contained IBM compatible computer system with an integrated liquid plasma video screen. The integrated video display unit will be connected to the CaverMap Surgical Aid Control unit by a standard RS-232 port. The CaverMap Surgical Aid Monitor reads data directly from the CaverMap Surgical Aid Control Unit through a RS232 port, which will be a modification to the current control unit design. The video monitor displays the data to the video screen in text and graphical format. Communication between the CaverMap Surgical Aid and the CaverMap Surgical aid Monitor is unidirectional.
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    K Number
    K010098
    Device Name
    MODIFICATION TO CAVERMAP SURGICAL AID
    Manufacturer
    UROMED CORP.
    Date Cleared
    2001-02-01

    (21 days)

    Product Code
    FGM
    Regulation Number
    876.4730
    Why did this record match?
    Product Code :

    FGM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K993436
    Device Name
    CAVERMAP SURGICAL AID
    Manufacturer
    UROMED CORP.
    Date Cleared
    2000-02-11

    (122 days)

    Product Code
    FGM
    Regulation Number
    876.4730
    Why did this record match?
    Product Code :

    FGM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The UroMed CaverMap® Surgical Aid is indicated for use in the stimulation of the cavernosal and associated parasympathetic nerves during open prostatectomy and colorectal (surgical) procedures in males. The device aids the surgeon in locating these nerves. The device is designed as an adjunct to the current open prostatectomy and colorectal procedures in which a nerve sparing technique is used. The Surgical Aid is not designed to replace the surgeon's expertise in mapping out the neurovascular bundles. Each surgeon's skill determines whether these nerves are spared regardless of any aid.
    Device Description
    The UroMed CaverMap Surgical Aid combines the technologies of two devices into one contained unit. The CaverMap Surgical Aid incorporates a nerve stimulator and a penile rigidity (tumescence) monitor into a single unit. The device is designed for identifying exposed nerves during open prostatectorny and colorectal surgical procedures. The device aid's the surgeon in locating the cavernosal and sacral nerves, which both effect tumescence.
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