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electrosurgical cutting and coagulation of soft tissue. Arthroscopic

The devices are tubular instruments, either 3mm or 5mm in diameter, with shaft lengths of 15cm. The intended use of the device is to electrosurgically cut and coagulate soft tissue during the performance of arthroscopic procedures. The energy source, Bipolar Electrosurgical Energy, is the same energy type as used for the previously cleared laparoscopic and thorascopic devices. The devices are constructed from the same materials and are processed similarly to the predicate devices. The device incorporates a return electrode on the distal end of the shaft eliminating the need for a return pad.

Electrosurgical Coagulation of soft tissue during ENT procedures.

The devices are Class II medical devices are similar in design to the referenced predicate devices. The BiTx devices are similar in construction and in component materials as compared to laparoscopic devices (Ref. BiLAP Probes submitted in 510(k) no's. K904993 and K945975). The devices are tubular instruments, either 3mm or 5mm in diameter, with shaft lengths of 12-15cm. The intended use of the device is to electrosurgically coagulate soft tissue during the performance of ENT procedures. The energy source, Bipolar Electrosurgical Energy, is the same energy type as used for the predicate devices with indications for ENT procedures. The device incorporates a return electrode on it's distal end, eliminating the need for a return pad.

Laparoscopic grasping of tissue. Laparoscopic bipolar coagulation. Laparoscopic contraceptive coagulation of the Fallopian tissue and may be used to achieve hemostasis following transection of the Fallopian tube.

The device is a Class III medical device. The Tubal Sterilization device is similar to Everest Medical's current laparoscopic BiCOAG® forceps submitted on 510(k) no. K945975 and the pre-ennactment Tubal sterilization Wolf Kleppinger Forceps.