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 2017_register executive 2017-03-01 article Rules and Regulations D09002ee1c7f28e4a D09002ee1c7f28ec8 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 amending the identification of manual gastroenterology-urology surgical instruments and accessories to reflect that the device does not include specialized surgical instrumentation for use with urogyencologic surgical mesh specifically intended for use as an aid in the insertion, placement, fixation, or anchoring of surgical mesh during urogynecologic procedures ("specialized surgical instrumentation for use with urogynecologic surgical mesh"). These amendments are being made to reflect changes made in the recently issued final reclassification order for specialized surgical instrumentation for use with urogynecologic surgical mesh. 82 FR 12171 https://www.govinfo.gov/app/details/FR-2017-03-01/2017-03997 2017-03997 fr01mr17-3 4164-01-P Docket No. FDA-2016-N-4661 https://www.govinfo.gov/app/details/FR-2017-03-01/2017-03997 https://www.govinfo.gov/content/pkg/FR-2017-03-01/html/2017-03997.htm https://www.govinfo.gov/content/pkg/FR-2017-03-01/pdf/2017-03997.pdf Gastroenterology-Urology Devices Medical Devices 1 p. 12171 12171 82 FR 12171 Title 21 Part 876 21 CFR Part 876 Gastroenterology-Urology Devices; Manual Gastroenterology-Urology Surgical Instruments and Accessories; Federal Register Vol. 82, Issue RULE 2017-03997 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2017-03-01 Docket No. FDA-2016-N-4661 4164-01-P 2017-03997 Final rule; technical amendment.

The Food and Drug Administration (FDA) is amending the identification of manual gastroenterology-urology surgical instruments and accessories to reflect that the device does not include specialized surgical instrumentation for use with urogyencologic surgical mesh specifically intended for use as an aid in the insertion, placement, fixation, or anchoring of surgical mesh during urogynecologic procedures ("specialized surgical instrumentation for use with urogynecologic surgical mesh"). These amendments are being made to reflect changes made in the recently issued final reclassification order for specialized surgical instrumentation for use with urogynecologic surgical mesh.

This rule is effective March 1, 2017. Sharon Andrews, Center for Devices and Radiological Health, 10903 New Hampshire Ave., Bldg. 66, Rm. G110, Silver Spring, MD 20993, 301-796-6529, Sharon.Andrews@fda.hhs.gov. Gastroenterology-Urology Devices Medical Devices Medical Devices: Gastroenterology-Urology Devices; Manual Gastroenterology-Urology Surgical Instruments and Accessories , Sharon.Andrews@fda.hhs.gov Vol. 82, no. 39 Office of the Federal Register, National Archives and Records Administration 2017-03-01 continuing daily deposited born digital 130 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2017-03-01 P0b002ee193d9a4ab 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr01mr17 https://www.govinfo.gov/app/details/FR-2017-03-01 https://www.govinfo.gov/content/pkg/FR-2017-03-01/pdf/FR-2017-03-01.pdf https://www.govinfo.gov/content/pkg/FR-2017-03-01/xml/FR-2017-03-01.xml fdlp 12167 12287 DGPO 2017-03-01 2024-06-01 FR-2017-03-01 machine generated eng FR FR-2017-03-01 82 39