{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled \"Premarket Notification (510(k)) Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgery.\" FDA has developed this guidance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. This draft guidance is not final nor is it in effect at this time.","action":"Notice.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2014/03/24/2014-06371.html","cfr_references":[],"citation":"79 FR 16009","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by June 23, 2014.","disposition_notes":null,"docket_ids":["Docket No. FDA-2014-D-0218"],"dockets":[],"document_number":"2014-06371","effective_on":null,"end_page":16010,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2014/03/24/2014-06371.xml","html_url":"https://www.federalregister.gov/documents/2014/03/24/2014-06371/premarket-notification-submissions-for-bipolar-electrosurgical-vessel-sealers-for-general-surgery","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2014-06371?publication_date=2014-03-24","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2014-03-24/2014-06371/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":157,"last_updated":"2026-07-25 22:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2014-03-24/pdf/2014-06371.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2014-06371.pdf?1395407018","publication_date":"2014-03-24","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2014/03/24/2014-06371.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2014-04-13T06:00:20Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":16009,"subtype":null,"title":"Premarket Notification Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgery; Draft Guidance for Industry and Food and Drug Administration Staff; Availability","toc_doc":"Premarket Notification Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgery","toc_subject":"Draft Guidance for Industry and Staff:","topics":[],"type":"Notice","volume":79}