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The RealHand™ High Dexterity (HD) instruments are intended for grasping, mobilization, dissection, transection, suturing, and/or electrocautery of tissue under direct and endoscopic visualization.

A new electroconductive pathway was added. This change consists of two basic modifications to the existing instruments: 1) a post was added to attach a third party generator via an insulated commercially available legally marketed cable. 2) an internal jumper was added to conduct current from the post to the internal shaft of the instrument. The substantial equivalence of the changes are based on a comparison of physical and functional attributes of the device contrasted with the Novare predicate and the indications of the Pajunk instruments. The place of manufacture has not changed. The physical appearance of the device, though slightly different, does not adversely affect the modified device. Functional expectations, material suitability, surgical technique and indications for use are just the same as the comparison devices placed in product code GCI by FDA. RealHand™ High Dexterity Instruments are substantially equivalent to the original instruments with respect to functionality and performance characteristics based the following criteria: 1) RealHand™ High Dexterity Instruments provide hemostatic clamping that allows electrocautery and ligature of tissue. The performance of the systems are essentially identical. 2) The RealHand™ High Dexterity Instruments were carefully evaluated and compared with the original Novare device. Documented testing established that the characteristics are equal to the original. 3) The original device was evaluated for proper function during use. The modified RealHand™ High Dexterity Instruments were evaluated using a valid test methodology, including electrocautery function and the test result was equivalent, and 4) the RealHand™ High Dexterity Instruments worked as intended.

The RealHand™ High Dexterity (HD) Instruments are intended for grasping, mobilization, dissection, transection and / or suturing of tissue under direct and endoscopic visualization.

The RealHand Instruments are single use, sterile instruments that consist of a handle, jaws, and a shaft which includes distal and proximal articulating sections. The instruments are similar in size to other instruments and are designed for use through an incision or appropriately sized surgical trocars/ports. The instrument jaws (or scissor blades) are activated by compressing and releasing the handle. The handle can include a ratchet and ratchet release which allow the instrument jaws to be locked in place, a rotation control wheel and articulation lock.

The Endolink™ True Movement System™ is intended for grasping, mobilization, dissection and transaction of tissue under direct and endoscopic visualization.

The Endolink™ True Movement System™ (Endolink Instruments) are single use, sterile instruments that consist of a handle, jaws, and a shaft which includes distal and proximal articulating sections. The Endolink Instruments are similar in size to other instruments and are designed for use through an incision or appropriately sized surgical trocars/ports. The instrument jaws (or scissors blades) are opened and closed by compressing and releasing the handle. The handle can include a ratchet and ratchet release which allow the instrument jaws to be locked in place.

The ENclose™ II Anastomosis Assist Device is intended for use by cardiac surgeons in place of partial occluding clamps during coronary artery bypass grafting (CABG) procedures requiring one to three proximal anastomoses in ascending aortas free of atheromatous disease.

The modified ENclose™ II Anastomosis Assist Device is an intraoperative device used to assist in the creation of one to three proximal anastomosis sites in the execution of coronary artery bypass grafting (CABG) procedures. Materials for the new device are identical to the previous device with the exception of the colorant. The proposed changes are limited to manufacturing/processing changes, a change in the colorant used in the existing plastic of the device, a change in the shape of the expandable region of the lower jaw and the addition of a fiber reinforced polymer hex driver to assist with deployment of the device if desired.

The ENclose™ Anastomosis Assist Device is intended for use by cardiac surgeons in place of partial occluding clamps during coronary artery bypass grafting (CABG) procedures requiring one to three anastomoses in ascending aortas free of atheromatous disease.

The modified ENclose™ Anastomosis Assist Device is a intraoperative device used to assist in the creation of one or more proximal anastomosis sites in the execution of coronary artery bypass grafting (CABG).

For Vascular Work Suitable for veins and arteries ENGAGE Jaw Inserts are used with a surgical clamp to occlude a blood vessel temporarily and may be used to clamp over indwelling catheters. ENGAGE Jaw Inserts are adaptable to Fogarty Hydragrip® Surgical Clamps.

ENGAGE Jaw Inserts are used with a surgical clamp to occlude a blood vessel temporarily and may be used to clamp over indwelling catheters. ENGAGE Jaw Inserts are adaptable to Fogarty Hydra-Grip Surgical Clamps. This surgical clamp is intended for use in vascular surgery.