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510(k) Data Aggregation
K Number
K111412Device Name
SURGISTEER SCISSORS, SURGISTEER DISSECTOR / GRASPER, SURGISTEER HOOK
Manufacturer
Date Cleared
2011-09-30
(133 days)
Product Code
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
STEERABLE TECHNOLOGIX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SurgiSteer™ line of of electrocautery laparoscopic instruments are sterile, single-use devices intended for use in a variety of minimally invasive surgical procedures to facilitate grasping, mobilization, dissection, and transection of tissue.
Device Description
The SurgiSteer™ line of electrocautery laparoscopic instruments are sterile, single-use disposable instruments intended for use through appropriately sized surgical trocars and consist of a proximal handle and a flexible distal end segment interconnected with a rigid 5.0 mm outer tube, all safely insulated for monoplolar electrocautery use. Distal to the distal end segment of the shaft is one of the end effectors (scissors, dissector/grasper, or hook) rotationally mounted independent of the outer tube and flexible end segment . Proximal to the end of the rigid shaft is an ergonomically shaped handle which contains: 1) a rotation knob that causes the end effector to rotate freely in both CW and CCW directions, 2) a bend wheel that causes the flexible end segment to bend >90 degrees in both left and right directions, and, 3) the actuating trigger that causes the articulating components of the end effector, if any, to open and close with sufficient force to either dissect or transect tissue. Each instrument has a monopolar energy supply cable that extends from the bottom of the handle and that can be plugged into the "the universal monopolar receptacle for footswitch-activated accessories on any commercially available generator.
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