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The NES Reprocessed RF Stylet (RFS) is intended for use in vessel and tissue coagulation including: - Treatment of incompetent (i.e. refluxing) perforator and tributaiy veins.

The NES Reprocessed RF Stylet (RFS) is a reprocessed VNUS RFS (510(k) # K052003). The device is a high frequency electrosurgical system designed for blood vessel and tissue coagulation in general surgical procedures. This device's energy source comes from a compatible and separately cleared Radiofrequency (RF) Generator. The device has been validated to be reprocessed a maximum of one time. The NES Reprocessed RF Stylet (RFS) is provided sterile (EtO) and is a single use, disposable device. The device is used in a healthcare facility. The device's function is to deliver RF energy to the desired treatment site and relay temperature and other information to the RF Generator. The device consists of one model. The device itself consists of the stylet shaft, handle and cable. A sharp is included with the device for patient insertion. The tip of the stylet serves to deliver the RF energy to the desired treatment site while the cable plugs into the RF generator (for power and relay temperature/other feedback). The tip, inner and outer lumen are the only patient-contacting parts. The patient-contacting material is as follows: AISI 304 SST and polyimide. All patient-contacting material has proven to be biocompatible. The non patient-contacting material is as follows: poly methyl methacrylate and polypropylene. The device is compatible with the separately cleared Radiofrequency (RF) Generator. The NES Reprocessed RF Stylet (RFS) is considered an external communicating device with circulating blood contact for a duration of less than 24 hours.