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The MEDISISS Reprocessed Harmonic FOCUS Curved Shears FCS9 is indicated for soft-tissue incisions when bleeding control and minimal thermal injury are desired. The instrument can be used as an adjunct to, or substitute for, electrosurgery, lasers, and steel scalpels in general, otorhinolaryngologic (ear, nose and throat [ENT]), plastic, pediatric, gynecologic, urologic, exposure to orthopedic structures (such as spine and joint space), and other open procedures.

MEDISISS Reprocessed Harmonic FOCUS Curved Shears FCS9 (originally manufactured by Ethicon Endo-Surgery). Following clinical use, the instruments are cleaned, refurbished, tested, inspected, packaged, sterilized with ethylene oxide and returned to the user facility by MEDISISS for an additional clinical use.

The SISS Inc. (d.b.a. MediSISS) Reprocessed electrosurgical instruments have applications in a variety of minimally invasive surgical procedures to manipulate and manage internal soft tissue by grasping, cutting, and/or to facilitate coagulation. transection, resection, mobilization, and dissections of tissue.

Reprocessed Electrosurgical Instruments mav consist of hand-manipulated devices with electrocautery capability and with or without rotation capability. The distal end of the Ethicon device consists of a scissor distal end configuration. The U.S Surgical device consists of a dissector distal end configuration. The devices are designed to be inserted through an appropriately sized trocar sleeve or cannula. The end effectors are operated by the handpiece handles may be designed to be suppressed and released to activate the instruments end-effector. The device's insulated shaft may be designed to (depending on the device model and type) be rotated (up to 360") either direction (using a knob on the handle.)

The MediSISS™ Reprocessed Phacoemulsification Tips/Needles are intended to emulsify and excise cataract tissue in ophthalmic microsurgical procedures.

Reprocessed Phacoemulsification Tips/Needles are specifically designed to be used to emulcataractous lens material and remove it from the eye (phacoemulsification). Electric energy is generated in the Phacoemulsification System, delivered in a headpiece, and is finally converted to ultrasonic energy delivered through a hollow titanium needle or tip. Irrigation fluid is delivered to the eye via a combination of an irrigation sleeve over the handpiece tip. The emulsified lens material is aspirated out of the eye through the center of the headpiece /tip assembly. The headpieces are routinely used repeatedly in multiple surgical procedures, while the tips are marketed as single use only.

The MediSISS Reprocessed Hot Biopsy Forceps and accessories are intended to be used endoscopically to obtain tissue specimens, remove polyps, and cauterize tissue.

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Reprocessed Trocars and Cannulas are intended to open and maintain a port of entry during endoscopic procedures.

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Reprocessed electrosurgical electrodes are intended to remove tissue and control bleeding during surgery by use of electrical current.

The devices that are the subject of this submission are used to remove tissue and control bleeding during surgery. They are made of a variety of materials and come in different shapes. They come from several different original equipment manufacturers as single use devices. Reprocessing includes cleaning. refurbishing, testing, packaging, and sterilization. It allows the electrodes to be used several times rather than just once.

The reprocessed arthroscopic shapers are accessories intended for use in arthroscopic procedures.

The devices that are the subject of this submission are used as accessories for shaping bone and soft tissue during arthroscopic procedures. They have a variety of names, such as shavers, burs, or trimmers, are made of a variety of materials, and come in many shapes and sizes. They come from several different original equipment manufacturers as single use devices. Reprocessing includes cleaning, refurbishing, testing, packaging, and sterilization. It allows the shapers to be used several times rather than just once.

The compression limb sleeves are designed to be used with a pump system to apply sequential compression to the lower limbs to prevent deep vein thrombosis.

The devices that are the subject of this submission are used with a pump system to apply sequential compression to the lower limbs. They are made of a variety of materials and come in various sizes. Some are leg wraps and some are foot wraps. They come from several different original equipment manufacturers as single use devices. Reprocessing includes cleaning, testing, packaging, and sterilization. It allows the compression limb sleeves to be used several times rather than just once.