federal_register: 2017-15892
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2017-15892 | Medical Devices; Obstetrical and Gynecological Devices; Classification of the Closed Loop Hysteroscopic Insufflator With Cutter-Coagulator | Rule | 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. | 2017-07-28 | 2017 | 7 | https://www.federalregister.gov/documents/2017/07/28/2017-15892/medical-devices-obstetrical-and-gynecological-devices-classification-of-the-closed-loop | https://www.govinfo.gov/content/pkg/FR-2017-07-28/pdf/2017-15892.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | 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,... |