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The Nucleotomy Catheter is intended to be used for the coagulation and decompression of disc material to treat symptomatic patients with contained herniated discs.

The Nucleotomy Catheter is a minimally invasive thermoelectric device. When used in The Nucleolonity Cuthers is a missanerator the Nucleotomy Catheter delivers thermal energy to targeted locations inside the disc. The distal portion of the tip is flexible such that the device can targeted locations instice the answ The flexible tip contains a resistive metal coil, which produces heat when current flows through it. The device contains a thermocouple for monitoring and controlling the temperature of the treated tissue.

The ORATEC® Ablator-S Probes are disposable, monopolar electrosurgical devices intended to be used for ablation, and hernostasis of soft tissues in arthroscopic procedures. They are designed to be used with the ORATEC® Vulcan™ EAS™ generator.

The devices described in this 510(k) are sterile, disposable devices designed for use with the ORATEC Vulcan™ EASTM RF generator.

The ORA-50 ElectroThermal System and Accessories are intended to be used for general surgical purposes, including orthopedic and arthroscopic applications, in coagulation of soft tissues. The ORA-50 ElectroThermal System and Accessories are intended for use by qualified medical personnel trained in the use of electrosurgical equipment.

The ORATEC Interventions ORA-50 ElectroThermal System ("ORA-50") is a single channel, 50-watt, electrothermal generator that offers finely controlled radiofrequency output for use during a variety of arthroscopic procedures. The ORATEC ORA-50 is specifically designed for use with ORATEC cutting and temperature controlled probes. Temperature and impedance monitoring are provided to assist the physician by automatically adjusting energy delivery to maintain effective tissue heating during temperature-controlled applications. Preset temperature and power settings in the generator software offer the convenience of quickly configuring the generator for use.

The ORATEC® SpineCATH™ Intradiscal Catheter is intended for use for the coagulation and decompression of disc material to treat symptomatic patients with annular disruption of contained herniated discs. The ORATEC SpineCATH Intradiscal Catheter is intended for use with ORATEC ElectroThermal™ Spine System Generator.

The devices described in this 510(k) are sterile, disposable devices intended for use with the ORATEC ElectroThermal Spine System Generator.

The ORA-50 S AutoTemp ElectroThermal Generator ("ORA-50 S") and Accessories are intended to be used for general surgical purposes in coagulation of soft tissues, in combination with ORATEC thermal/coagulating probes. The ORA-50 S ElectroThermal Generator and Accessories are intended for use by qualified medical personnel trained in the use of electrosurgical equipment.

The ORATEC Interventions ORA-50 S AutoTemp ElectroThermal Spine System ("ORA-50 S") is a single channel, 50-watt, electrothermal generator that offers finely controlled radiofrequency output for the coagulation of soft tissue during a variety of spine procedures. The ORATEC ORA-50 S is specifically designed for use with ORATEC spine probe devices, although it may be used with any ORATEC electrosurgical or electrothermal probe. Temperature and impedance monitoring are provided to assist the physician by automatically adjusting energy delivery to maintain effective tissue heating during temperature-controlled applications. Preset temperature and power settings in the generator software offer the convenience of quickly configuring the generator for use. A programmed temperature profile mode specifically designed for use with the ORATEC SpineCATH™ device ("SpineCATH Intradiscal Catheter", K974464) offers the convenience of selecting a treatment profile.

The Vulcan EAS ElectroThermal Arthroscopy System and Accessories are intended to be used for general surgical purposes, including orthopedic and arthroscopic applications, in coagulation, ablation, and hemostasis of soft tissues in combination with ORATEC temperature controlled, cutting, and ablation probes. The VULCAN EAS ElectroThermal Arthroscopy System and Accessories are intended for use by qualified medical personnel trained in the use of electrosurgical equipment. Contraindications for Use: The use of the VULCAN EAS ElectroThermal Arthroscopy System and Accessories are contraindicated, when in the judgment of the physician, an electrosurgical procedure would be contrary to the best interest of the patient.

The ORATEC Interventions, Inc., VULCAN EAS ElectroThermal Arthroscopy System generator is a single channel, 200-watt, electrothermal generator that offers finely controlled radiofrequency output for the electrocoagulation, cutting, and ablation of soft tissue during a variety of arthroscopic procedures. The unit is specifically designed to be used with ORATEC electrothermal, electrosurgical, and ablation probes. Temperature and impedance monitoring are provided to assist the surgeon by automatically adjusting energy delivery to maintain effective tissue heating during temperature controlled applications. Accessories provided with the Vulcan EAS include: - AC power cord . - Probe extension cable . - Dual-pedal footswitch control . Each generator is also accompanied by Instructions for Use and a warranty registration card.

The Bipolar Ablation Probes are disposable, bipolar electrosurgical devices intended to be used for ablation and hemostasis of soft tissues in arthroscopic procedures. They are designed to be used with the ORATEC® Vulcan™ EAS™ generator.

The ORATEC Bipolar Ablation Probes are disposable, bipolar electrosurgical devices designed to cut or ablate soft tissues. They provide minimally invasive access to the targeted tissues. The Bipolar Ablation Probes are used in conjunction with the ORATEC Vulcan™ EAS™ RF generator to deliver bipolar radiofrequency (RF) energy for ablation of soft tissues. The probes consist of an insulated shaft, an insulated power electrode, a return electrode, and a handle. Probes may incorporate suction capability for the removal of ablated tissue from the surgical site.