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510(k) Data Aggregation
K Number
K103128Device Name
CADWELL DISPOSABLE MONOPOLAR / BIPOLAR / CONCENTRIC / FLUSH TIP /BALL TIP PEDICLE SCREW STIMULATOR PROBE,
Manufacturer
CADWELL LAB, INC.
Date Cleared
2011-02-23
(121 days)
Product Code
ETN
Regulation Number
874.1820Why did this record match?
Applicant Name (Manufacturer) :
CADWELL LAB, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Cadwell Disposable Stimulator Probe is used to perform localized stimulation of neural tissue and to locate, identify and monitor cranial motor nerves, peripheral nerves and spinal nerve roots during surgery. The Cadwell Disposable Stimulator Probe is a single patient use device.
Device Description
Cadwell Disposable Stimulator Probes come sterilized in three electrical configurations and multiple lengths to accommodate stimulating through cannulas during minimally invasive surgeries: Disposable Concentric Probes -Localized stimulation due to coaxial nature of active and reference electrodes. Tip diameter approx 1mm. Particularly useful when working with a microscope. Disposable Concentric Probes may be bent by user to facilitate viewing access under a microscope. Disposable Bipolar Probes -Both active and return electrode are built into the probe. Both tips of the Disposable Bipolar Probe must be in contact with tissue for stimulation current to flow. The Bipolar Probe will stimulate a small amount of tissue, more than Concentric Probes, but less than Monopolar probes. Disposable Bipolar Probes may be bent to facilitate viewing access under a microscope. Disposable Monopolar Probe -The Monopolar Probe has a single active electrode and must be used in conjunction with a remote return electrode connected to the patient. The Monopolar probe is insulated to the tip with only a stimulating "ball" or "tip" exposed. Disposable Monopolar Probes may be bent to facilitate viewing access under a microscope.
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