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Found 16 results
510(k) Data Aggregation
K Number
K232632Device Name
Racz Neurostat RF Generator
Manufacturer
Epimed International
Date Cleared
2024-05-24
(268 days)
Product Code
GXD
Regulation Number
882.4400Why 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
K200624Device Name
Percutaneous Introducer
Manufacturer
Epimed International Inc.
Date Cleared
2020-04-27
(48 days)
Product Code
BSO
Regulation Number
868.5120Why 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
K190256Device Name
Rulo Radiofrequency Lesion Probe
Manufacturer
Epimed International, Inc.
Date Cleared
2019-03-08
(29 days)
Product Code
GXI
Regulation Number
882.4725Why 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
K133316Device 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
868.5120Why 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
K072005Device Name
RK EPIDURAL NEEDLE
Manufacturer
EPIMED INTERNATIONAL
Date Cleared
2008-02-07
(199 days)
Product Code
BSP
Regulation Number
868.5150Why 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
K053318Device Name
RX EPIDURAL NEEDLE
Manufacturer
EPIMED INTERNATIONAL, INC.
Date Cleared
2006-02-17
(79 days)
Product Code
BSP
Regulation Number
868.5150Why 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
K051171Device Name
STINGRAY EPIDURAL CATHETER CONNECTOR
Manufacturer
EPIMED INTERNATIONAL, INC.
Date Cleared
2005-08-26
(112 days)
Product Code
CAZ
Regulation Number
868.5140Why 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
K051860Device Name
FLEXIBLE INTRODUCER CANNULA, MODEL 135-1837
Manufacturer
EPIMED INTERNATIONAL, INC.
Date Cleared
2005-08-22
(45 days)
Product Code
MIA
Regulation Number
868.5150Why 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
K043467Device Name
FLEXIBLE SPINAL NEEDLE
Manufacturer
EPIMED INTERNATIONAL, INC.
Date Cleared
2005-03-31
(106 days)
Product Code
BSP
Regulation Number
868.5150Why 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
K041021Device Name
RF INTRODUCTION CANNULA
Manufacturer
EPIMED INTERNATIONAL, INC.
Date Cleared
2004-09-16
(149 days)
Product Code
GXI, GXD
Regulation Number
882.4725Why 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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