Gastroenterology-Urology Devices; Manual Gastroenterology-Urology Surgical Instruments and Accessories
other · Food and Drug Administration · Rule · Published 2017-03-01 · Effective 2017-03-01 · 82 FR 12171
Document
Document number
2017-03997
Federal Register citation
82 FR 12171
CFR reference
21 CFR 876
Type
Rule
Action
Final rule; technical amendment.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2017-03-01
Effective date
2017-03-01
HHS docket
Docket No. FDA-2016-N-4661
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.