743c1697-f712-4bde-8a4b-07dfe25e2ae9UpdatePublished42019-08-212018-02-09In Commercial DistributionB331ONX2020PrimaryHIBCCSilexONX-2020362145604SILEX MEDICAL, LLC1Hook ScissorfalsefalsefalsefalsefalsefalsetruetruefalsefalsefalsefalsefalseLabeling does not contain MRI Safety InformationtruefalseK914910000K933387000K94626300033596Endoscopic electrosurgical handpiece/electrode, monopolar, reusableAn electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery. It includes a long thin electrode connected to the handpiece, and may include a lumen for suction/irrigation; it is available in a variety of forms (e.g., forceps or snare with ring handles, rigid probe with controls) and requires a patient contact return electrode to complete the circuit. This is a reusable device.falseActive35080Rigid endoscopic tissue manipulation forceps, reusableA rigid, hand-held manual surgical instrument designed to be introduced through the working channel of an endoscope and/or an endoscopic port (e.g., laparoscopic port) primarily for grasping and manipulating tissues during endoscopic surgery. It has proximal controls (e.g., scissors-like handles), a rigid long slender shaft, and distal grasping jaws; it is not an electrosurgical device and is not dedicated to biopsy. This is a reusable device.falseActiveGEIElectrosurgical, Cutting & Coagulation & AccessoriesGCJLaparoscope, General & Plastic SurgeryfalsetrueMoist Heat or Steam Sterilization