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510(k) Data Aggregation

    K Number
    K083250
    Device Name
    NEUROMED ELECTROANALGESIC DELIVERY SYSTEMS
    Manufacturer
    AA NEUROMED CORP.
    Date Cleared
    2009-08-18

    (287 days)

    Product Code
    GZJ, IPF, LIH
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    AA NEUROMED CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Pain Management for use with interferential and/or TENS mode programs/parameters Stimulate peripheral nerves for the purpose of providing pain relief. Management and symptomatic relief of chronic (long-term) intractable pain. Adjunctive treatment of post-traumatic pain. Adjunctive treatment in the management of post-surgical pain. Muscle Stimulation for use with muscle stimulation programs Increasing local blood circulation. Maintaining or increasing range of motion. Muscle Re-education. Relaxation of muscle spasms. Prevention or retardation of disuse atrophy. Immediate post-surgical stimulation of the calf muscles to prevent venous thrombosis.
    Device Description
    NeuroMed Electroanalgesic Delivery Systems consist of a system console with a control and display panel, control electronics and software and device accessories including a suction cup electrode applicator, electrodes and cables. The device uses regular household current as a power source. The physical measurements of the device are 17.5" long x 11.5" wide x 5.5" high at a weight of approximately 9 Ibs. NeuroMed Electroanagesic Delivery Systems is an electrical signal generator which applies sinusoidal current through two pairs of contact electrodes using temporal interference patterns to stimulate muscles and peripheral nerves transcutaneously for the purpose of providing pain relief or as an adjunctive treatment in physical therapy. Alternatively, this device can perform the forementioned functions by applying sinusoidal current through only one pair of electrodes.
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    K Number
    K010213
    Device Name
    MODIFICATION TO CAVERMAP SURGICAL AID
    Manufacturer
    UROMED CORP.
    Date Cleared
    2001-04-20

    (87 days)

    Product Code
    ETN
    Regulation Number
    874.1820
    Why did this record match?
    Applicant Name (Manufacturer) :

    UROMED CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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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?
    Applicant Name (Manufacturer) :

    UROMED CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K000507
    Device Name
    CAVERMAP SURGICAL AID
    Manufacturer
    UROMED CORP.
    Date Cleared
    2000-04-21

    (66 days)

    Product Code
    ETN
    Regulation Number
    874.1820
    Why did this record match?
    Applicant Name (Manufacturer) :

    UROMED CORP.

    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?
    Applicant Name (Manufacturer) :

    UROMED CORP.

    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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    K Number
    K982226
    Device Name
    UROMED BRACHYTHERAPHY IODINE-125 SOURCES
    Manufacturer
    UROMED CORP.
    Date Cleared
    1999-05-13

    (323 days)

    Product Code
    KXK
    Regulation Number
    892.5730
    Why did this record match?
    Applicant Name (Manufacturer) :

    UROMED CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The UroMed Brachytherapy Iodine-125 Sources are intended for use in the treatment of cancer with radioactive sources in close proximity to or within the tumor. The UroMed I-125 Radionuclide Brachytherapy Sources are indicated for the treatment of selected localized tumors. These sources are commonly used to treat superficial, intra-abdominal, and intrathoracic tumors. Tumors of the head, neck, lung, pancreas and prostate are commonly treated. They may be used alone, or in combination with external beam radiation.
    Device Description
    UroMed I-125 Sources are cylindrical sealed sources containing iodine-125 radioactivity. The sources are 4.5mm long and 0.8mm in diameter. The outer capsule of the source is composed of titanium, and is sealed at each end by a laser weld. The iodine-125 is deposited within a porous ceramic tube as silver iodide (AgI). A radiopaque marker is located in the center of the ceramic tube to serve as an x-ray marker. The marker will be composed of gold alloy or iridium. Iodine seeds have a half-life of 59.6 days and are available in a range of activity levels. The UroMed I-125 Sources are provided non-sterile and must be sterilized prior to use.
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    K Number
    K980717
    Device Name
    UROMED SLING KIT
    Manufacturer
    UROMED CORP.
    Date Cleared
    1998-05-22

    (87 days)

    Product Code
    KNA
    Regulation Number
    884.4530
    Why did this record match?
    Applicant Name (Manufacturer) :

    UROMED CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The UroMed Sling Kit is intended to be used in a suburethral sling procedure for the alleviation of involuntary leakage of urine due to urinary incontinence in adult women. The UroMed Sling Kit is indicated for use by the surgeon for placing a urethral sling. The kit provides instruments to help the surgeon place the sling beneath the urethra. The kit will be used in suburethral sling procedures for female urinary incontinence due to urethral hypermobility and/or intrinsic sphincter deficiency.
    Device Description
    The UroMed Sling Kit is a single use, manual surgical kit for use during suburethral sling procedures. The kit will be used to place a sling (autograph, allograph, or synthetic) beneath the urethra in suburethral sling procedures. The kit is comprised of two needles, two sheaths and two loops. The kit components are constructed out of the following materials: Needle: Surgical Stainless Steel, meeting ASTM Specification F899-84, with a handle constructed of Polyethylene Terephthalate (PET-P). Sheath: Polyethylene Loop: Surgical Stainless Steel, meeting ASTM Specification F899-84, with Polyethylene shaft
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    K Number
    K974600
    Device Name
    UROMED PATCH
    Manufacturer
    UROMED CORP.
    Date Cleared
    1998-03-31

    (112 days)

    Product Code
    MNG
    Regulation Number
    876.5160
    Why did this record match?
    Applicant Name (Manufacturer) :

    UROMED CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The UroMed Patch is indicated for the prevention or decrease of urine leakage in women with stress urinary incontinence. The UroMed Patch is indicated for the prevention or decrease of episodes of urine leakage in women with stress urinary incontinence.
    Device Description
    The UroMed Patch is a single use, disposable foam pad that is coated on one side with an adhesive gel. The patch is worn over the urethra between times of unination. The product is intended to prevent unine form escaping the environs of the urethra, and is replaced each time the patient urinates.
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    K Number
    K974137
    Device Name
    UROMED NEEDLE GRASPER
    Manufacturer
    UROMED CORP.
    Date Cleared
    1998-01-30

    (88 days)

    Product Code
    OCW, KOG
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    UROMED CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The UroMed Needle Grasper is intended to be used during endoscopic/laparoscopic surgical procedures to hold a suture needle allowing for suture passing. The UroMed Needle Grasper is indicated for use by the endoscopic/laparoscopic surgeon for internal suturing under direct vision. The device is designed to grasp a suture needle for manipulation by the surgeon. The device will be used in bladder neck suspension procedures for female urinary incontinence due to urethral hypermobility.
    Device Description
    The UroMed Needle Grasper is a single use, manual surgical instrument for use during endoscopic/laparoscopic surgical procedures. The Needle Grasper will be used through an endoscopic/laparoscopic operating channel or under open surgical procedures. The instrument will be used to place and pass suture in bladder neck suspension procedures (urethropexy). The device is constructed out of Surgical Stainless Steel with a handle constructed of medical grade polymers.
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    K Number
    K970971
    Device Name
    URO MED NERVE STIMULATOR
    Manufacturer
    UROMED CORP.
    Date Cleared
    1997-10-27

    (224 days)

    Product Code
    ETN
    Regulation Number
    874.1820
    Why did this record match?
    Applicant Name (Manufacturer) :

    UROMED CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Urovations Nerve Stimulator is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability. The Urovations Nerve Stimulator is indicated for use in the stimulation of the cavernosal nerves during open prostatectomy (surgical) procedures, aiding the surgeon in locating these nerves. The device is designed as an adjunct to current open prostatectomy procedures in which a nerve sparing technique is used. The Nerve Stimulator is not designed to replace the surgeon's expertise in mapping out the vascular bundles. Each surgeon's skill determines whether these nerves are spared regardless of any aid.
    Device Description
    The Urovations Nerve Stimulator is a electrical Nerve Stimulator designed for use during open prostatectomy (surgical) procedures. The stimulator provides a biphasic current pulse with variable amplitude between 1 - 20mA, a constant pulse width of 800usec/phase, and a constant frequency of 16Hz. The stimulation is applied to the body by the surgeon in order to locate and test the excitability of the cavernosal nerves.
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