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Found 13 results
510(k) Data Aggregation
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
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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K Number
K041843Device Name
PENCIL POINT NEEDLE
Manufacturer
EPIMED INTERNATIONAL, INC.
Date Cleared
2004-08-24
(47 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 Blunt Nerve Block Needle is intended for the administration of anesthetic agents to provide regional anesthesia.
Device Description
The Blunt Nerve Block Needle consists of a stainless steel cannula with an atraumatic 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 stainless steel wire shaft and a molded plastic hub. The Blunt Nerve Block 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
K023140Device Name
VERSA-KATH EPIDURAL CATHETER, MODEL 156-2124
Manufacturer
EPIMED INTERNATIONAL, INC.
Date Cleared
2003-08-15
(329 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
For administration of anesthetic agents into the epidural space to provide continuous epidural or caudal anesthesia for up to 72 hours.
Device Description
The Versa-Kath Epidural Catheter consists of a stainless steel spring lumen with a dual coating. The inner coating is Polyester tube and the outer coating is Fluorinated Ethylene Polypropylene tube. A stylet is also provided with the device which consists of a stainless steel wire and a molded plastic hub. The Versa-Kath will be provided as a sterile, single use, disposable device. The Versa-Kath will be a 21 gauge catheter available in various lengths.
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K Number
K030562Device Name
TUOHY EPIDURAL NEEDLE
Manufacturer
EPIMED INTERNATIONAL, INC.
Date Cleared
2003-04-03
(41 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 Epidural Needle is intended for the epidural placement, directly or through an epidural catheter, of anesthetic agents to elicit regional anesthesia.
Device Description
The Tuohy 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 stainless steel wire shaft and a molded plastic hub. The Tuohy Epidural Needle will be provided as a sterile, single use, disposable device. The Epidural Needle will be available in a variety of lengths and gauges.
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