The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Premarket Notification (510(k)) Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgery.'' FDA has developed this guidance document to assist industry in preparing premarket notification (510(k)) submissions for bipolar electrosurgical vessel sealers intended for use in general surgery.
Document
Premarket Notification Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgery; Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Premarket Notification (510(k)) Submissions for Bipolar Electrosurgica...
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81 FR 54102
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“Premarket Notification Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgery; Guidance for Industry and Food and Drug Administration Staff; Availability,” thefederalregister.org (August 15, 2016), https://thefederalregister.org/documents/2016-19402/premarket-notification-submissions-for-bipolar-electrosurgical-vessel-sealers-for-general-surgery-guidance-for-industry-.