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The Maestro System is intended to hold and position laparoscopes and laparoscopic instruments during laparoscopic surgical procedures.

The Moon Maestro System is a 2-arm system which utilizes software and hardware to provide support to surgeons for manipulating and maintaining instrument position. Motors compensate for gravitational force applied to laparoscopic instruments, while surgeon control is not affected. Conventional laparoscopic tools are exclusively controlled and maneuvered by the surgeon, who grasps the handle of the surgical laparoscopic instrument and moves it freely until the instrument is brought to the desired position. Once surgeon hand force is removed, the Maestro system reverts to maintenance of the specified tool position and instrument tip location. This 510(k) is being submitted to implement design changes to the previously cleared Maestro System. The following modifications have been implemented to the Maestro System: - · System Positioning Guidance - · System Hold Status Indication - Instrument Coupling - · System Setup - Bedside Setup Joint Control

The Maestro System is intended to hold and position laparoscopic instruments during laparoscopic surgical procedures.

The Moon Maestro System utilizes software and hardware to provide support to surgeons for manipulating and maintaining instrument position. Motors compensate for gravitational force applied to laparoscopic instruments, while surgeon control is not affected. Conventional laparoscopic tools are exclusively controlled and maneuvered by the surgeon, who grasps the handle of the surgical laparoscopic instrument and moves it freely until the instrument is brought to the desired position. Once surgeon hand force is removed, the Maestro system reverts to maintenance of the specified tool position and instrument tip location.

The STERIS® 5085 SRT is a general surgical table with high patient weight capacity, extended width capability, and lower minimal table top elevation. The STERIS® 5085 SRT accommodates all general surgical procedures including but not limited to, cardiac and vascular, endoscopic, gynecology, urology, nephrectomy, neurology, ophthalmologic, orthopedics and other procedures requiring intraoperative fluoroscopic C-arm imaging and also supports laparoscopic surgical technique for the largest surgical patients. The STERIS® 5085 SRT enables patient transport on hard level surfaces within the surgical suite (from pre-operative areas to the operating room and again from the operating room to post operative recovery).

The STERIS® 5085 SRT Surgical Table is a mobile, electro-hydraulically operated surgical table designed to support all general surgical procedures including cardiac and vascular, endoscopic, gynecology, urology, nephrectomy, neurology, ophthalmology and orthopedics with the addition of STERIS table accessories. The STERIS® 5085 SRT Surgical Table features powered lateral tilt, Trendelenburg / reverse Trendelenburg, Zip-Slide™ movable tabletop, and adjustable height functions. The STERIS® 5085 SRT has a patient transport feature that allows the user to transport patients to and from the surgical suite on hard level surfaces.

The OPT 80 Mobile Operating Table is designed for use during diagnostic examinations or surgical procedures to support and position a patient. It is made up of a column, movable tabletops and trolley. The tabletops allow trendelenburg, and reverse trendelenburg positioning, lateral tilting as well as back, leg and head plate movement. It has side rails for fitting additional accessories as may be required by a particular procedure. The table system is designed to hold a patient of 180 Kg. (400 Lbs.) in the positions described in the Instruction Manual and the attached Standard Equivalency Table.

The OPT 80 Mobile Operating Table is designed for use during diagnostic examinations or surgical procedures to support and position a patient. It is made up of a column, movable tabletops and trolley. The tabletops allow trendelenburg, and reverse trendelenburg positioning, lateral tilting as well as back, leg and head plate movement. It has side rails for fitting additional accessories as may be required by a particular procedure. The table system is designed to hold a patient of 180 Kg. (400 Lbs.) in the positions described in the Instruction Manual and the attached Standard Equivalency Table. There are secondary back-up operating devices to allow operation of the table should the primary control or power supply fail.

Devices are intended to attach boot stirrups to operating revm table rail or cysto table rail during surgical or diagnostic procedures requiring positioning and support of the patient's legs.

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The AMSCO® Surgical Table is a mobile, electro-hydraulically operated general surgical table that provides flexible articulation and image amplification of the surgical patient.

mobile, electro-hydraulically operated general surgical table

Drager Gemina System is a nonpowered piece of durable The equipment intended to provide wall mounted physical support for medical/surgical monitoring and related equipment, storage space, and wall mounted dispensing of medical gases and electrical power required in patient care clinical settings, emergency rooms, intensive care, procedure rooms and operating rooms. The Gemina System will be used in the same indications as other systems which provide overhead or wall mounted physical support and storage of equipment for dispensing of medical gases and electrical power.

The Gemina System is a wall mounted supply system of modular design. The individual components of this modular system are wall fixture, horizontal element, column, support tube, and equipment carrier (shelf). column contains two large terminal plates that can be The outfitted according to the individual need with various outlets for gas supply, electricity, vacuum, communications, etc.

8080 System is a piece of durable equipment The Drager DVE intended to provide ceiling mounted overhead physical support anaesthesia machines, medical/surgical monitoring and for and ceiling mounted related equipment, storage space, dispensing of medical gases and electrical power required in clinical settings, emergency rooms, intensive care, procedure rooms and operating rooms. 8080 will be used in the same indications as the DVE The DVE 4000 System and the DVE 8000/1/2 System and the Drager 8032E which provide physical support, storage space, and overhead, ceiling mounted dispensing of medical gases and electrical The DVE 4000 has previously been reviewed by FDA power. (K921297). The Drager 8000/1/2 Series System and the combined DVE 8000/1/2 with DVE 4002 have been previously reviewed by FDA (K942043). The new DVE 8080 Series will be used in indications which are the same as indications for the DVE 4000, DVE 8000, for other pendant systems currently offered for DVE 8032E and commercial distribution in the United States.

The DVE 8080 Series System is a ceiling mounted overhead supply system of modular design. The individual components of any modular system are divided into four categories: ceiling fixture, support systems, pendant head or column, and equipment carrier. The pendant column contains four terminal plates that can be outfitted according to the individual need with various outlets for gas supply, electricity, vacuum, communications, etc. Add-on terminal boxes are available. The support system consists of either a fixed vertical support tube (DVE 8080 basic version of the series) or a single (DVE 8081) support arm or two (DVE 8082) support arms. The support arms are equipped with pneumatic brakes and are available in three combinable lengths. The DVE 8080 Series System rotates laterally and is powered for up and down adjustment. The motor used in the DVE 8080 is an induction motor manufactured by Gefeg GmbH & Co KG. An equipment shelf provides for better positioning of the medical devices required and can be installed at time of purchase or added-on afterwards. Shelves are available in one standard size: 620 mm (width) by 400 mm.