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Found 11 results
510(k) Data Aggregation
K Number
K241045Device Name
Disposable Subdermal Needle Electrode, Corkscrew
Manufacturer
Technomed Europe
Date Cleared
2024-12-11
(238 days)
Product Code
GXZ, IKT
Regulation Number
882.1350Why did this record match?
Applicant Name (Manufacturer) :
Technomed Europe
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Needle Electrodes for neurological purposes are intended for use with recording, monitoring equipment for the recording of biopotential signals including electroencephalograph (EEG), electromyograph (EMG) and nerve potential signals, and are intended for stimulation/recording with stimulation/recording equipment for electromyograph (EMG) and nerve potential signals.
Device Description
Disposable Subdermal Needle Electrodes, Corkscrew are single-patient use electrodes, delivered Ethylene Oxide (EtO) sterilized. They include a needle at one end which is connected to a lead wire with a 1.5 mm female safety DIN 42802 connector. The needle, which is fabricated using stainless steel, is formed into a corkscrew shape, with a regular bevel tip. The connecting lead wire, which may be supplied in different lengths and colors is terminated with a DIN 42802 connector to enable connection to recording or monitoring / stimulation equipment.
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K Number
K130136Device Name
DISPOSABLE AND REUSABLE CONCENTRIC NEEDLE ELECTRODES,DISPOSABLE AND REUSABLE SUBDERMAL NEEDLE ELECTRODES,
Manufacturer
TECHNOMED EUROPE
Date Cleared
2013-07-19
(182 days)
Product Code
GXZ
Regulation Number
882.1350Why did this record match?
Applicant Name (Manufacturer) :
TECHNOMED EUROPE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Needle Electrodes for Neurological purposes are intended for use with recording, monitoring equipment for the recording of biopotential signals including electroencephalograph (EEG), electromyograph (EMG) and nerve potential signals, and are intended for stimulation/recording with stimulation/recording equipment for electromyograph (EMG) and nerve potential signals.
Device Description
Needle Electrodes are passive devices used for recording, monitoring and stimulation during EEG, EMG, nerve conducting studies and IONM. The Needle Electrodes have different tip shapes for performing different recording and stimulating procedures.
The Needle Electrodes are disposable and designed for single use and are labeled accordingly. The disposable Needle Electrodes are delivered sterile and can be used after opening of the sterile package.
The needles are comprised of a stainless steel or platinum alloy needle, electrically connected to a lead wire. or with a connector for connection to a separate lead wire. Monopolar needles are coated with a polytetrafluoroethylene coating. In case of a pre-connected lead wire the other end is a regular industry standard DIN 42802 safety connector.
The needles are invasive as they are used subcutaneously. Positioning and use is under supervision of a licensed physician.
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K Number
K121257Device Name
LARYNGEAL ELECTRODE
Manufacturer
TECHNOMED EUROPE
Date Cleared
2012-08-28
(124 days)
Product Code
ETN
Regulation Number
874.1820Why did this record match?
Applicant Name (Manufacturer) :
TECHNOMED EUROPE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Non-invasively monitoring of the laryngeal nerves during thyroid surgery, and of the Xth cranial nerve during skull-base surgery.
Device Description
Disposable Laryngeal Electrodes are non-invasive. The disposable device is constructed using a medical grade ink as electrode material suspended on a polyethylene substrate; a polyester connector with a separate available cable assembly or DIN 42802 connectors; The electrode is available in three sizes to suit different sexes and age groups. The 4/5mm electrode should be used with an 4 or 5mm endotracheal tube; the 6/7mm electrode should be used with a 6 or 7mm endotracheal tube; the 8/9mm electrode should be used with an 8 or 9mm endotracheal tube. The cable assembly is available separately and will have a long life if it is not abused and is stored appropriately. Using the laryngeal electrode lowers the risk of damage to the laryngeal or Xth cranial nerve (the Vagus nerve) during thyroidectomy or parathyroidectomy and, since it is noninvasive, it also lessens the risk of infection during the monitoring procedure.
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K Number
K110422Device Name
SURGICAL STIMULATORS
Manufacturer
TECHNOMED EUROPE
Date Cleared
2011-05-26
(101 days)
Product Code
ETN
Regulation Number
874.1820Why did this record match?
Applicant Name (Manufacturer) :
TECHNOMED EUROPE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Technomed Europe Kartush disposable surgical stimulators are indicated for tissue dissection and stimulation of cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots.
Device Description
Kartush Disposable surgical stimulators are invasive devices used in the tissue dissection and monopolar stimulating. The instruments have different tip shapes for performing different dissection and stimulating procedures. The tip, tapered shaft, handle and connection pin are made of 1 pieces material. The instruments are designed for single-patient/multiple application use. The detachable lead wire has a safety DIN 42802 connector.
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K Number
K073532Device Name
DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES
Manufacturer
TECHNOMED EUROPE
Date Cleared
2008-05-01
(136 days)
Product Code
GXY
Regulation Number
882.1320Why did this record match?
Applicant Name (Manufacturer) :
TECHNOMED EUROPE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Disposable Adhesive Surface Electrodes are intended for use with recording, monitoring and stimulation equipment for the purpose of stimulating/recording of biopotential signals. Electrodes are applied in the study of biopotentials such as Electroencephalograph (EEG), surface Electromyography (EMG), nerve conduction and Evoked potential signals (EP). Electrodes are non-invasive as they are applied to the patient's skin using a self-adhesive solid-gel surface. The electrodes are non-sterile and for single patient use only.
Device Description
Disposable Adhesive Surface Electrodes are non-invasive. Cutaneous devices are used in the acquisition of signals for the purpose of stimulating, monitoring and recording Electroencephalograph (EEG), surface Electromyography (EMG) and Evoked Potentials (EP). The electrodes are designed for single-patient/multiple application use and are very flexible. Because of the adhesive nature of the gel, no securing material is required for fixating the electrode to the patient's skin. There are two types of electrodes, one with fixed lead wire and the other without lead wire, tab electrodes. The electrodes with lead wire have a safety DIN 42802 connector, several lengths and color combinations. Tab electrode can be connected, using a lead wire with alligator clip, to the gel free contact strip at the electrode end.
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K Number
K072016Device Name
CUP ELECTRODES, GOLD, REUSABLE, SILVER, REUSABLE; CUP ELECTRODES SILVER/SILVER CHLORIDE REUSABLE
Manufacturer
TECHNOMED EUROPE
Date Cleared
2007-10-19
(88 days)
Product Code
GXY
Regulation Number
882.1320Why did this record match?
Applicant Name (Manufacturer) :
TECHNOMED EUROPE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cup Electrodes are intended for non-invasive use with recording and monitoring equipment, (active and reference), of Electromyography (EMG), Electroencephalograph (EEG) and Evoked Potentials.
Device Description
A cutaneous electrode is an electrode that is applied directly to a patient's skin to record physiological signals. In other words cutaneous devices are used in the acquisition of signals for the purpose of monitoring and recording Electroencephalograph (EEG), Electroencephalography (EEG), and Evoked Potentials (EP) and the electroencephalographic/evoked potentials reading is a completely non-invasive procedure that can be applied repeatedly to patients, normal adults, and children with virtually no risk or limitation. The electrodes are delivered non sterile and are available in reusable and disposable versions.
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K Number
K063729Device Name
DISPOSABLE PEDICLE SCREW PROBE, MODEL 3603-00
Manufacturer
TECHNOMED EUROPE
Date Cleared
2007-08-21
(249 days)
Product Code
GXZ
Regulation Number
882.1350Why did this record match?
Applicant Name (Manufacturer) :
TECHNOMED EUROPE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To locate, identify and monitor cranial motor nerves, peripheral nerves and spinal nerve roots during surgery.
Device Description
Disposable pedicle screw probes are used as the medium to deliver electrical stimulation to tissue during intraoperative neurological monitoring. The disposable pedicle screw probes are supplied sterile and are for single use only. The disposable pedicle screw probes are connected to an electrical stimulator using a flexible lead wire and a "touch-proof" safety connector on the distal end. Disposable pedicle screw probes require a separate stimulator return electrode. Disposable pedicle screw probes are used by the surgeon to locate and identify spinal nerve roots and to assess nerve function. The disposable pedicle screw probes are designed with a plastic handle and stainless steel active electrode shaft insulated to the tip. The disposable pedicle screw probes shaft may be bent to allow viewing access under a microscope.
Technomed Europe Disposable pedicle screw probes consist of an insulated probe shaft mounted to plastic handle. The probe shaft is electrically connected to a DIN 42802 "touch-proof" safety connector on the other end. The electrode is supplied in a sterile pouch.
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K Number
K062437Device Name
DISPOSABLE HYPODERMIC EMG NEEDLE ELECTRODE TECHNOMED EUROPE VERSION AND PRIVATE LABELED
Manufacturer
TECHNOMED EUROPE
Date Cleared
2007-02-16
(189 days)
Product Code
IKT
Regulation Number
890.1385Why did this record match?
Applicant Name (Manufacturer) :
TECHNOMED EUROPE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The disposable hypodermic EMG needle electrode is used for muscle stimulation, motor unit action potential recording and drug delivery. The motor nerves are monitored by detecting EMG activity in the muscles they innervate.
The drug used should be Botox Botilium Toxin type A.
Note: Technomed Europe does not supply any drugs with the Disposable hypodermic EMG needle electrodes nor does Technomed Europe offer for sale any form of drugs.
Device Description
The disposable hypodermic EMG needle electrode is designed for single use only. It consists of a stainless steel cannula electrically insulated with a PTFE coating, except for the lancet point and the inner surface of the tube. The coating is to ensure easy skin penetration and to ensure electrical insulation on the entire cannula, except for the point.
A husk fitting together with a wire with connection to an extension cable has been attached to the cannula. This cable will enable the electrical signal to be transferred to a stimulating or recording device.
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K Number
K050325Device Name
DISPOSABLE CONCENTRIC PROBE, DISPOSABLE BIPOLAR PROBE, DISPOSABLE MONOPOLAR PROBE
Manufacturer
TECHNOMED EUROPE
Date Cleared
2005-05-05
(85 days)
Product Code
GXZ
Regulation Number
882.1350Why did this record match?
Applicant Name (Manufacturer) :
TECHNOMED EUROPE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The disposable probe is used:
- to locate and identify cranial motor nerves during ENT and intra-cranial procedures
- to locate and identify cranial and peripheral motor nerves during surgery, including spinal nerve roots
- to locate, identify and monitor cranial motor nerves during surgery
The motor nerves are monitored by detecting EMG activity in the muscles they innervate.
Device Description
There are three types of disposable probes: Concentric, Bipolar and Monopolar
Disposable Concentric probe The Concentric probe is very precise and has a diameter of only 1 mm. They are especially useful when working with the microscope, and allow the surgeon to differentiate between cranial nerves, to stimulate within the Internal Auditory Canal, or to stimulate fine fibers of the extra-cranial nerve without stimulating surrounding tissue.
Disposable Bipolar probe The Bipolar probe has both the active and return electrode builds in to the probe. Both tips of the Bipolar probe must come into contact with tissue in order for the stimulation current to flow. The Bipolar probe will stimulate through a small amount of tissue. The Bipolar probe may be used in skull-base surgery and those involving peripheral motor nerves.
Disposable Monopolar probe The Monopolar probe has a single active electrode, but must have a remote return electrode connected to the patient. The Monopolar probe is insulated to a tip free coating length of 2 mm, so it is capable of very precise stimulation. The probe should be touched onto the tissue until the nerve is located. The Monopolar probe is designed to be used to stimulate the tumor mass or when a large spread is required.
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K Number
K042375Device Name
SMK, CX, CXE, RCN
Manufacturer
TECHNOMED EUROPE
Date Cleared
2004-10-26
(55 days)
Product Code
GXI, GXD
Regulation Number
882.4725Why did this record match?
Applicant Name (Manufacturer) :
TECHNOMED EUROPE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A RF Injection Needle is an injection needle, which may be used either for percutaneous nerve blocks with local anesthetic solution or for radio frequency lesioning. The nerve is localized either by using electrical stimulation 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 or a radio frequency lesion may be made.
Device Description
There are four types of needles: SMK, CXE, CX and RCN
SMK is used in radiofrequency (RF) lesion procedures for the relief of pain. The device allows an injection of local anesthetic to relieve the pain of RF. A SMK-TC electrode is then place into the cannulae to create the lesion. The length of the cannula is insulated except for a section of the tip. The RF energy is then transferred from the electrode through this uninsulated portion which heats the surrounding tissue to create a lesion.
CXE is used for percutaneous facet denervations. The device consists of a shaft of hypodermic tubing, which is insulated except for 5mm at the tip. Plastic tubing and an electrical lead are unitized in a single flexible leader portion, which connects to the shaft. The lead is insulated and feed through the plastic tube. A Luer hub on the tubing allows injection of local anesthetic. The needle can be connected to a Radionics generator for stimulation and lesioning. The RF pole does not allow for temperature monitoring.
CX is used for percutaneous stimulation and injection. The design of the pole is similar to the RF pole except for the exposed tip. Only the beveled surface, 1mm, is uninsulated. The pole is intended to be connected to a stimulus generator.
RCN is used for prognostic block injections of local anesthetics or injection of contrast media. The device consists of hvoodermic tubing attached PVC tubing. The needle has no electrical connection. The tubing has a Luer hub to allow the injection with a syringe at a more remote position from the needle field.
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