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510(k) Data Aggregation
K Number
K090608Device Name
MINTA RYAN RF THERMOCOUPLE ELECTRODE (RYAN-50, 100, 150 AND 200), MINTA INTERMEDIATE CABLE (RYAN-C, -R, -B)
Manufacturer
Date Cleared
2010-06-14
(465 days)
Product Code
Regulation Number
882.4725Why did this record match?
Applicant Name (Manufacturer) :
MINTA MEDICAL LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Minta Radiofrequency Thermocouple Electrodes are indicated for use in the lesioning of peripheral nerve tissue.
Device Description
The Minta Ryan RF Thermocouple Electrodes are used in conjunction with the commercially available Neurotherm (K011387), RF Lesion Generators and Pajunk RF disposable cannula (K060397) to create radiofrequency (RF) lesioning of peripheral nerve tissue. The Minta Ryan RF Thermocouple Electrode is a temperature sensor (thermocouple) which is used to deliver RF energy to the tissue. The RF energy is then transferred from the electrode which heats the surrounding tissue to create a lesion. The thermocouple also measures the temperature at the tip of the electrode. The Minta Ryan RF Thermocouple Electrodes are provided as non-sterile re-usable devices (re-processed single use). The Minta Ryan RF Thermocouple Electrode will be available in a variety of lengths and gauges. The Minta Ryan RF Thermocouple Electrode consists of a stainless steel shaft, a PET (polyethylene terephthalate) hub; a non-latex silicone rubber insulated electrical lead and a plug connector.
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