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SureTek Compression Sleeves are intended for use with a compatible pump controller for intermittent compression of the lower extremities so as to increase venous return as a prophylaxis to Deep Vein Thrombosis.

Compression Sleeves are inflatable cuffs designed to apply intermittent pressure to the foot, calf or thigh in order to increase venous return and prevent pooling of blood associated with the formation of Deep Vein Thrombosis (DVT). The devices consist of inflatable vinyl bladder(s) lined with an outer non-woven fabric; the bladder is connected to pneumatic tubing for connection with a compatible pump system that controls the sleeve's pressure cycle. Hook-and-loop fasteners sewn into the fabric are used to secure the sleeve to the foot or leg. Models are available in a range of dimensions in order to fit varying foot, calf and thigh circumferences. Reprocessed sleeves have identical technological characteristics as the predicate devices, i.e. device materials, dimensions, operating principle and system compatibility are unchanged during reprocessing. SureTek sleeves are provided as sterile, while the manufacturer product is provided non-sterile.

Suretek Reprocessed Laparoscopic Instruments are intended for use during general and laparoscopic surgery for cutting, grasping, dissection and electrocautery of tissue.

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SureTek Reprocessed Electrosurgical Electrodes are intended for use during general, arthroscopic and endoscopic surgery for RF ablation, resection or coagulation of soft tissue and hemostasis of blood vessels.

Devices are monopolar and bipolar electrosurgical electrodes designed for ablation, resection and coagulation of soft tissue. Instruments consist of one or more distal electrodes, an insulated shaft, and a proximal handle with electrical connections to a compatible electrosurgical unit. Monopolar instruments require concurrent use of a compatible return electrode. Models have varying electrode configurations and tip angles. Some models are equipped with suction tubing for continuous cooling of the ablation site and aspiration of fluids/debris during use. Reprocessed electrodes have equivalent technological characteristics as the predicate devices, i.e. device design, dimensions, energy delivery and system compatibility are unchanged during reprocessing. Device materials are identical with the exception of shaft insulation, which may be replaced with a comparable heat shrink material.

SureTek Reprocessed Arthroscopic Blades and Burs are intended for use during arthroscopic and endoscopic procedures for cutting and resection of soft tissue, cartilage and bone. Endoscopic sinus surgery is limited to small diameter instruments (2 to 3.5mm).

Arthroscopic Shavers and Burs are powered instruments designed for cutting of soft tissue, cartilage and bone during arthroscopic/endoscopic surgeries. The stainless steel instrument consist of a hollow shaft with a distal blade or bur that rotates within an open-ended cannula with outer diameters ranging from 2 to 6 mm. Devices are designed for use only with compatible driver systems with continuous irrigation and aspiration of fluids through the inner shaft during use. Depending upon the aggressiveness required for cutting, shavers are designed with different serrated and non-serrated blades and angles, and burs have varying shapes (round, barrel, tapered) and number flutes (4 to 12). Reprocessed blades and burs have identical technological characteristics as the predicate devices, i.e. device component materials, dimensions and system compatibility are unchanged during reprocessing.