CDRH Industry: Premarket Notification [510(k)] Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgery - Draft Guidance for Industry and FDA Staff

FDA has developed this guidance document to assist industry in preparing premarket notification submissions [510(k)] for bipolar electrosurgical vessel sealers intended for use in general surgery. These devices are designed to seal isolated blood and lymphatic vessels for hemostasis (as an alternative to ties) through the use of high frequency electrical current between two electrodes in close proximity.  For more information, please see http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm383205.htm