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510(k) Data Aggregation

    K Number
    K230205
    Device Name
    Veloxion System
    Manufacturer
    Corinth MedTech, Inc.
    Date Cleared
    2023-02-24

    (30 days)

    Product Code
    FJL, GEI, KQT
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    Corinth MedTech, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Veloxion System is intended for use by trained urologists for endoscopically controlled tissue chip resection and coagulation, and removal of prostate adenomas via suction channel under continuous flow conditions following resection using a bipolar resecting device.
    Device Description
    The Veloxion System consists of the following components: - Veloxion Controller (with Integrated Fluid Control and video) - Footswitch - Veloxion Resectoscope - Veloxion Fluid Control Set - Veloxion Roll Stand The Veloxion System also includes the following Class I accessories for handling of waste collected from the patient (these items only handle waste after it is already outside the patient), which includes: - Waste Management Tubing: To provide a conduit for transfer of aspirated fluids and tissue from the patient and from under the patient's buttocks drape - Tissue Catch: For collection of gross resected tissue pieces for pathology. The Veloxion System provides bipolar resection and coagulation of prostate adenomas, it distends the cavity by filling with saline and it provides pressure control of the cavity to facilitate viewing with the integrated Resectoscope.
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    K Number
    K191341
    Device Name
    Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags
    Manufacturer
    Corinth MedTech, Inc.
    Date Cleared
    2019-06-13

    (24 days)

    Product Code
    FJL, GEI, KQT
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    Corinth MedTech, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Veloxion System is intended for use by trained urologists for endoscopically controlled tissue chip resection and coagulation, and removal of prostate adenomas and bladder tumors (TURBT) via suction channel under continuous flow conditions following resection using a bipolar resectoscope.
    Device Description
    The Veloxion System consists of the following components: - Veloxion Controller (with Integrated Fluid Control) - Footswitch - Veloxion Resectoscope - Veloxion Fluid Control Set - Veloxion Video Control Unit - Veloxion Roll Stand The Veloxion System also includes the following Class I accessories for handling of waste collected from the patient (these items only handle waste after it is already outside the patient), which includes: - Waste Management Tubing: To provide a conduit for transfer of aspirated fluids and tissue from the patient and from under the patient's buttocks drape - Tissue Catch: For collection of gross resected tissue pieces for pathology. - Waste Management Bags: To provide bags for final collection of outflow. The Veloxion System provides bipolar resection and coagulation of intrauterine tissue, it distends the uterus by filling with saline, it provides pressure control of the intrauterine cavity for insufflation to facilitate viewing with the integrated hysteroscope and it monitors the fluid deficit (potential fluid absorbed by the patient's body) to the physician established limit. The components of Veloxion System perform the following functions: - The Veloxion Controller provides bipolar radiofrequency outputs (for cut and coagulation) and fluid/pressure control through the use of two integrated peristaltic pumps, provides the user interface to establish the desired set pressure, monitors intracavitary pressure using dual independent pressure sensors mechanically connected to the Veloxion Fluid Control Set irrigation lumen. The software then monitors, controls and notifies the user when the limits are reached or when specific conditions are met. - The Veloxion Resectoscope is a sterile single use hand held bipolar radiofrequency device configured to provide camera and light for visualization of the anatomy for the resection of tissue and aspiration of resected chips. Fluid inflow and aspiration of the resected chips are controlled by the Controller's peristaltic pumps. - The Veloxion Fluid Control Set is a sterile single use device that provides conduits for fluid inflow, aspiration of resected tissue and fluids and a diaphragm (pressure membrane) that provides mechanism for the Controller to measure cavity pressure (through the irrigation lumen) during the procedure thereby facilitating the insufflation function. - The Veloxion Video Control Unit provide control of the camera, light, display image to a commercially available monitor, stores image and video selected by the user from a session, and provides a USB connection for a USB Stick download of stored media by the user. - The Veloxion Roll Stand enables monitoring of saline remaining in the saline bag and facilitates the fluid deficit function.
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    K Number
    K191335
    Device Name
    Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags
    Manufacturer
    Corinth MedTech, Inc.
    Date Cleared
    2019-06-06

    (20 days)

    Product Code
    HIH, GEI, HIG
    Regulation Number
    884.1690
    Why did this record match?
    Applicant Name (Manufacturer) :

    Corinth MedTech, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Veloxion System is intended for intrauterine use by trained gynecologists for endoscopically controlled tissue chip resection and coagulation, and removal of intrauterine polyps and myomas and benign conditions requiring endometrial ablation via suction channel under continious flow conditions following resection using a bipolar resectoscope. It is also intended to distend the uterus by filling with saline to facilitate viewing and to monitor the volume differential between fluid flowing into and out of the uterus.
    Device Description
    The Veloxion System consists of the following components: - Veloxion Controller (with Integrated Fluid Control) - Footswitch - Veloxion Resectoscope - Veloxion Fluid Control Set - Veloxion Video Control Unit - Veloxion Roll Stand The Veloxion System also includes the following Class I accessories for handling of waste collected from the patient (these items only handle waste after it is already outside the patient), which includes: - Waste Management Tubing: To provide a conduit for transfer of aspirated fluids and tissue from the patient and from under the patient's buttocks drape - Tissue Catch: For collection of gross resected tissue pieces for pathology. - Waste Management Bags: To provide bags for final collection of outflow. The Veloxion System provides bipolar resection and coagulation of intrauterine tissue, it distends the uterus by filling with saline, it provides pressure control of the intrauterine cavity for insufflation to facilitate viewing with the integrated hysteroscope and it monitors the fluid deficit (potential fluid absorbed by the patient's body) to the physician established limit.
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    K Number
    K190113
    Device Name
    Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags
    Manufacturer
    Corinth MedTech, Inc.
    Date Cleared
    2019-04-24

    (90 days)

    Product Code
    HIH, GEI, HIG
    Regulation Number
    884.1690
    Why did this record match?
    Applicant Name (Manufacturer) :

    Corinth MedTech, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Veloxion System is intended for intrauterine use by trained gynecologists for endoscopically controlled tissue chip resection and coagulation, and removal of intrauterine polyps and myomas via suction channel under continuous flow conditions following resection using a bipolar resectoscope. It is also intended to distend the uterus by filling with saline to facilitate viewing and to monitor the volume differential between fluid flowing into and out of the uterus.
    Device Description
    The Veloxion System consists of the Veloxion Controller (with Integrated Fluid Control), Footswitch, Veloxion Resectoscope, Veloxion Fluid Control Set, Veloxion Video Control Unit, and Veloxion Roll Stand. It also includes Class I accessories for waste handling: Waste Management Tubing, Tissue Catch, and Waste Management Bags. The system provides bipolar resection and coagulation, distends the uterus with saline, controls intrauterine pressure, and monitors fluid deficit.
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    K Number
    K190099
    Device Name
    Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch
    Manufacturer
    Corinth MedTech, Inc.
    Date Cleared
    2019-03-15

    (52 days)

    Product Code
    FJL, GEI, KQT
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    Corinth MedTech, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Veloxion System is intended for use by trained urologists for endoscopically controlled tissue chip resection and coagulation, and removal of prostate adenomas via suction channel under continuous flow conditions following resection using a bipolar resecting device.
    Device Description
    The Veloxion System consists of the following components: Veloxion Controller (with Integrated Fluid Control) with Footswitch, Veloxion Resectoscope, Veloxion Fluid Control Set, Veloxion Video Control Unit, and Veloxion Roll Stand. The system also includes Class I accessories for handling waste: Waste Management Tubing and Tissue Catch. The system provides bipolar resection and coagulation of prostate adenomas, distends the cavity by filling with saline, and provides pressure control of the cavity to facilitate viewing with the integrated Resectoscope.
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    K Number
    K180752
    Device Name
    Veloxion System, Veloxion Controller Kit, Veloxion Resecting Device Kit, Veloxion Fluid Control Set, Veloxion Saline Pole
    Manufacturer
    Corinth MedTech, Inc.
    Date Cleared
    2018-07-25

    (125 days)

    Product Code
    HIH, GEI, HIG
    Regulation Number
    884.1690
    Why did this record match?
    Applicant Name (Manufacturer) :

    Corinth MedTech, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Veloxion System is intended for intrauterine use by trained gynecologists for endoscopically controlled tissue chip resection and coagulation, and removal of intrauterine polyps and myomas via suction channel under continuous flow conditions following resection using a bipolar resecting device. It is also intended to distend the uterus by filling with saline to facilitate viewing with a hysteroscope and to monitor the volume differential between into and out of the uterus.
    Device Description
    The Veloxion System consists of the following components: - Veloxion Controller (with Integrated Fluid Control) - Footswitch - Veloxion Resecting Device Kit: - Veloxion Resecting Device - Sheath - Continuous Flow Optical Obturator - Veloxion Fluid Control Set - Veloxion Saline Pole The Veloxion System also includes the following Class I accessories for handling of waste collected from the patient (these items apply no aspiration to the patient, they only handle waste after it is already outside the patient), which includes: - Waste Accessory Bag for collection of waste aspirated form the patient and from under patient's buttocks, - Waste Accessory Tubing for collection of waste from under the patient's buttocks - Waste Management Pump for moving the waste to the Waste Bag. The Veloxion System provides bipolar resection and coagulation of intrauterine tissue, it distends the uterus by filling with saline, it provides pressure control of the intrauterine cavity for insufflation to facilitate viewing with a hysteroscope and it monitors the fluid deficit (potential fluid absorbed by the patient's body) to the physician established limit.
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    K Number
    K162979
    Device Name
    Veloxion System
    Manufacturer
    Corinth MedTech, Inc.
    Date Cleared
    2017-03-24

    (149 days)

    Product Code
    FJL, GEI, KQT
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    Corinth MedTech, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Veloxion System is intended for endoscopically controlled tissue chip resection and coagulation, and removal of prostate adenomas via suction channel under continuous flow conditions following resection using a bipolar resecting device.
    Device Description
    The Veloxion System consists of the following components: - Veloxion Controller (with Integrated Fluid Control) - o Footswitch - Veloxion Resecting Device Kit: ● - o Veloxion Resecting Device - o Sheath - 0 Continuous Flow Optical Obturator - Veloxion Fluid Control Set ● - Veloxion Saline Pole ● The Controller provides bipolar radiofrequency outputs (cut and coagulation) and fluid control through the use of two integrated peristaltic pumps. The Resecting Device is a disposable, hand held bipolar radiofrequency device configured for the resection and aspiration of resected chips. Fluid inflow and aspiration of the resected chips are controlled by the Controller's peristaltic pumps, in conjunction with the disposable Fluid Control Set, which provides continuous inflow and aspiration during the procedure.
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