United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2014_register executive 2014-03-22 article Notices D09002ee1c7fa4998 D09002ee1c7fa4a37 United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Premarket Notification (510(k)) Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgery."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 This draft guidance is not final nor is it in effect at this time. 79 FR 16009 https://www.govinfo.gov/app/details/FR-2014-03-24/2014-06371 2014-06371 fr24mr14-73 4160-01-P Docket No. FDA-2014-D-0218 https://www.govinfo.gov/app/details/FR-2014-03-24/2014-06371 https://www.govinfo.gov/content/pkg/FR-2014-03-24/html/2014-06371.htm https://www.govinfo.gov/content/pkg/FR-2014-03-24/pdf/2014-06371.pdf 2 p. 16009 16010 79 FR 16009 Premarket Notification Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgery; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Federal Register Vol. 79, Issue NOTICE 2014-06371 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2014-D-0218 4160-01-P 2014-06371 Notice.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Premarket Notification (510(k)) Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgery."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 This draft guidance is not final nor is it in effect at this time.

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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by June 23, 2014. Joshua Nipper, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G404, Silver Spring, MD 20993-0002, 301-796-6524. Draft Guidance for Industry and Staff: Premarket Notification Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgery , CDRH-Guidance@fda.hhs.gov http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm http://www.regulations.gov Vol. 79, no. 56 Office of the Federal Register, National Archives and Records Administration 2014-03-24 continuing daily deposited born digital 274 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2014-03-24 P0b002ee1880f162c 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr24mr14 https://www.govinfo.gov/app/details/FR-2014-03-24 https://www.govinfo.gov/content/pkg/FR-2014-03-24/pdf/FR-2014-03-24.pdf https://www.govinfo.gov/content/pkg/FR-2014-03-24/xml/FR-2014-03-24.xml fdlp 15909 16171 DGPO 2014-03-22 2024-06-03 FR-2014-03-24 machine generated eng FR FR-2014-03-24 79 56