Gastroenterology-Urology Devices; Manual Gastroenterology-Urology Surgical Instruments and Accessories. Final rule; technical amendment

Fed Regist. 2017 Mar 1;82(39):12171.

Abstract

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.

MeSH terms

  • Equipment Safety / classification
  • Gastroenterology / classification*
  • Gastroenterology / instrumentation
  • Humans
  • Surgical Instruments / classification*
  • Surgical Mesh
  • Urology / classification*
  • Urology / instrumentation