Medical Devices; Obstetrical and Gynecological Devices; Classification of the Closed Loop Hysteroscopic Insufflator With Cutter-Coagulator
fda-device · Food and Drug Administration · Rule · Published 2017-07-28 · Effective 2017-07-28 · 82 FR 35071
Document
Document number
2017-15892
Federal Register citation
82 FR 35071
CFR reference
21 CFR 884
Type
Rule
Action
Final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2017-07-28
Effective date
2017-07-28
HHS docket
Docket No. FDA-2017-N-1914
Abstract
The Food and Drug Administration (FDA, Agency, or we) is classifying the closed loop hysteroscopic insufflator with cutter- coagulator into class II (special controls). The special controls that will apply to the device are identified in this order, and will be part of the codified language for the closed loop hysteroscopic insufflator with cutter-coagulator classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.