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510(k) Data Aggregation

    K Number
    K232632
    Device Name
    Racz Neurostat RF Generator
    Manufacturer
    Epimed International
    Date Cleared
    2024-05-24

    (268 days)

    Product Code
    GXD
    Regulation Number
    882.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Epimed International

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Racz Neurostat RF Generator is intended for lesioning of neural tissue. It is indicated for use in the peripheral nervous system. It is to be used with Epimed RF probes and cannula.
    Device Description
    The Racz Neruostat RF Generator is a touchscreen controlled Radio Frequency (RF) Generator used to lesion neural tissue for pain management. It has 4 outputs for delivering RF from a single source into the patient, it includes functions for nerve stimulation (Sensory and Motor), Continuous Thermal RF Lesioning, Pulsed RF Lesioning and Pulsed Dose RF Lesioning. The RF Energy is transmitted via each individual probe and a Neutral Electrode when in monopolar mode; or between probes when running in bipolar mode. The device will monitor the patient's impedance, probe temperature, along with the voltage and current of the RF Energy during a procedure.
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    K Number
    K200624
    Device Name
    Percutaneous Introducer
    Manufacturer
    Epimed International Inc.
    Date Cleared
    2020-04-27

    (48 days)

    Product Code
    BSO
    Regulation Number
    868.5120
    Why did this record match?
    Applicant Name (Manufacturer) :

    Epimed International Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Percutaneous Introducer is intended to allow for the percutaneous placement of devices, needles or probes, in close proximity to nerves and around or into surgical wound or non-surgical wound sites. It may be used to inject or aspirate the introduction area via the luer hub of the needle/introducer.
    Device Description
    The Percutaneous Introducer is a single-use, disposable device consisting of a flexible polymer sheath with a molded plastic hub. The device incorporates a stainless steel needle inside the flexible cannula and is removed after the introducer is placed. The inserted stainless steel introducer needle has a sharp distal point. The flexible cannula acts as a conduit for percutaneous introduction of medical devices, such as catheters, needles, or probes. A stylet or porous plug (to prevent aspiration during insertion) comes seated in the standard 6 degree luer fitting of the proximal end of the needle hub. The Percutaneous Introducers are used for a short period of time and are supplied sterile and non-pyrogenic. The Percutaneous Introducer is available in four lengths and a 14 gauge.
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    K Number
    K190256
    Device Name
    Rulo Radiofrequency Lesion Probe
    Manufacturer
    Epimed International, Inc.
    Date Cleared
    2019-03-08

    (29 days)

    Product Code
    GXI
    Regulation Number
    882.4725
    Why did this record match?
    Applicant Name (Manufacturer) :

    Epimed International, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RuloTM Radiofrequency Lesion Probe is an injection probe which may be used either for percutaneous nerve blocks with local anesthetic solution or for radiofrequency lesioning. A nerve is localized either by electrostimulation through the needle or by injecting contrast medium through the needle and using radiography concomitantly. The nerve may then be blocked by injecting local anesthetic solution or a radiofrequency lesion may be made.
    Device Description
    The Rulo™ Radiofrequency Lesion Probe (Rulo Probe) creates radiofrequency (RF) lesions on nerves and can also create percutaneous nerve blocks by delivering anesthetic to the site. It is a single-use, surgically invasive device. It is inserted with the use of a flexible introducer accessory to contact a nerve in an area of the spine for less than 15 minutes to treat pain. The RF energy creates a lesion on nerve tissue that conducts pain signals. The tissue's ability to conduct electrical signals is disrupted by the lesion. The targeted nerve can be localized either by using RF electrostimulation through the cannula or by injecting contrast medium through the cannula with the use of the fluid injection port and using radiography concomitantly. The nerve may be blocked by injecting local anesthetic solution or making an RF lesion. The device is used by a trained physician in a clinical setting. The device is constructed with a steel cannula and uses a variety of polymers for the insulation, hub, cable, connector, cap and fluid injection port.
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    K Number
    K133316
    Device Name
    SPIROL BLOCK (19 GA. OPEN END MODELS), (20 GA. OPEN END MODELS), (19 GA. CLOSED END MODELS), (20 GA. CLOSED END MODELS)
    Manufacturer
    EPIMED INTERNATIONAL, INC.
    Date Cleared
    2014-05-28

    (212 days)

    Product Code
    BSO
    Regulation Number
    868.5120
    Why did this record match?
    Applicant Name (Manufacturer) :

    EPIMED INTERNATIONAL, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Spirol® Block Continuous Peripheral Nerve Block Catheter permits placement of catheters next to nerve plexuses for continuous nerve block anesthesia or analgesia techniques including upper extremity, lower extremity, abdominal and paravertebral locations for periods not exceeding 72 hours.
    Device Description
    Epimed's Spirol® Block Continuous Peripheral Nerve Block Catheter has the following characteristics: - · 19 Ga. & 20 Ga., 14" to 24" in length. - · Offered in open and closed end distal tip configurations. - · Offered in styletted and non-styletted versions. - · Internal radiopaque, echogenic coiled reinforced wire to allow visibility under fluoroscopy and/or ultrasound. - · Catheters to be provided in sterile kit/set style configurations or as a standalone replacement catheter. The catheter is a single-use, disposable device consisting of a polymer coated stainless steel spring. The catheter is available in various lengths, as well as open-ended or closed-ended configurations; the closed-ended models having three eyes (injection ports) at the distal end. The Spirol® Block is also available in styletted or non-styletted versions, as well as 19 Ga. or 20 Ga. models.
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    K Number
    K072005
    Device Name
    RK EPIDURAL NEEDLE
    Manufacturer
    EPIMED INTERNATIONAL
    Date Cleared
    2008-02-07

    (199 days)

    Product Code
    BSP
    Regulation Number
    868.5150
    Why did this record match?
    Applicant Name (Manufacturer) :

    EPIMED INTERNATIONAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RK Epidural Needle is indicated for either single injection of drug or placement of an Epimed Spring Guided Catheter or traditional epidural catheter.
    Device Description
    The RK Epidural Needle consists of a stainless steel cannula with a ground beveled distal tip. A plastic hub is molded onto the proximal end of the cannula. A stainless steel stylet with a molded plastic hub is also provided with the device. The RK Epidural Needle will be provided as a sterile, single use, disposable device. The RK Epidural Needle will be available in a variety of lengths and gauges.
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    K Number
    K053318
    Device Name
    RX EPIDURAL NEEDLE
    Manufacturer
    EPIMED INTERNATIONAL, INC.
    Date Cleared
    2006-02-17

    (79 days)

    Product Code
    BSP
    Regulation Number
    868.5150
    Why did this record match?
    Applicant Name (Manufacturer) :

    EPIMED INTERNATIONAL, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RX Epidural Needle is intended for the epidural placement, directly or through an epidural catheter, of anesthetic agents to elicit regional anesthesia.
    Device Description
    The RX Epidural Needle consists of a stainless steel cannula with a ground beveled distal tip. A plastic hub is molded onto the proximal end of the cannula. A stylet is also provided with the device which consists of a custom trimmed shaft and a molded plastic hub. The RX Epidural Needle will be provided as a sterile, single use, disposable device. The RX Epidural Needle will be available in a variety of lengths and gauges.
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    K Number
    K051171
    Device Name
    STINGRAY EPIDURAL CATHETER CONNECTOR
    Manufacturer
    EPIMED INTERNATIONAL, INC.
    Date Cleared
    2005-08-26

    (112 days)

    Product Code
    CAZ
    Regulation Number
    868.5140
    Why did this record match?
    Applicant Name (Manufacturer) :

    EPIMED INTERNATIONAL, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Stingray Epidural Catheter Connector is intended to provide various anesthetic and fluid administration devices with a single, common access point to an epidural catheter for delivery of anesthetics. The connector is used in conjunction with an epidural catheter for continuous administration of anesthetic agents.
    Device Description
    The Stingray Epidural Catheter Connector consists of two molded plastic body Sections that mate in a twist and lock motion. Between the two Sections is a molded bushing that compresses and grips an epidural catheter.
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    K Number
    K051860
    Device Name
    FLEXIBLE INTRODUCER CANNULA, MODEL 135-1837
    Manufacturer
    EPIMED INTERNATIONAL, INC.
    Date Cleared
    2005-08-22

    (45 days)

    Product Code
    MIA
    Regulation Number
    868.5150
    Why did this record match?
    Applicant Name (Manufacturer) :

    EPIMED INTERNATIONAL, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Flexible Introducer Cannula is intended for the epidural placement, directly The Flexible Introducer cannuid is Inventour of the opents to elicit regional anesthesia.
    Device Description
    The Flexible Introducer Cannula consists of a plastic cannula with a molded plastic hub. The device is also packaged with a stainless steel introducer needle which is removed after the device has been placed.
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    K Number
    K043467
    Device Name
    FLEXIBLE SPINAL NEEDLE
    Manufacturer
    EPIMED INTERNATIONAL, INC.
    Date Cleared
    2005-03-31

    (106 days)

    Product Code
    BSP
    Regulation Number
    868.5150
    Why did this record match?
    Applicant Name (Manufacturer) :

    EPIMED INTERNATIONAL, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Flexible Spinal Needle is intended for the administration of anesthetic agents to provide regional anesthesia.
    Device Description
    The Flexible Spinal Needle consists of a coated flexible stainless steel cannula with a molded plastic hub. A stylet is also provided with the device which consists of a stainless steel cannula and a molded plastic hub. The Flexible Spinal Needle will be provided as a sterile, single use, disposable device and will be available in a variety of lengths and gauges.
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    K Number
    K041021
    Device Name
    RF INTRODUCTION CANNULA
    Manufacturer
    EPIMED INTERNATIONAL, INC.
    Date Cleared
    2004-09-16

    (149 days)

    Product Code
    GXI, GXD
    Regulation Number
    882.4725
    Why did this record match?
    Applicant Name (Manufacturer) :

    EPIMED INTERNATIONAL, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Epimed RF Introduction Cannula is intended for use in radiofrequency (RF) heat lesion procedures for the relief of pain.
    Device Description
    The Epimed RF Introduction Cannula consists of a coated stainless steel cannula with a stainless steel stylet and molded plastic hub. The cannula will be available in various lengths, gauges and tip configurations.
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