Gastroenterology-Urology Devices; Manual Gastroenterology-Urology Surgical Instruments and Accessories
Information
Type
Rule
Regulated products
Published
March 1, 2017
Last updated
March 1, 2017
Description
Document number 2017-03997. 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.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)