{"abstract":"The Food and Drug Administration (FDA) is classifying the gynecologic laparoscopic power morcellation containment system 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 gynecologic laparoscopic power morcellation containment system's 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.","action":"Final order.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2016/06/21/2016-14627.html","cfr_references":[{"chapter":null,"citation_url":null,"part":884,"title":21}],"citation":"81 FR 40181","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This order is effective June 21, 2016. The classification was applicable on April 7, 2016.","disposition_notes":null,"docket_ids":["Docket No. FDA-2016-N-1318"],"dockets":[],"document_number":"2016-14627","effective_on":"2016-06-21","end_page":40183,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2016/06/21/2016-14627.xml","html_url":"https://www.federalregister.gov/documents/2016/06/21/2016-14627/medical-devices-obstetrical-and-gynecological-devices-classification-of-the-gynecologic-laparoscopic","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2016-14627?publication_date=2016-06-21","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2016-06-21/2016-14627/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":499,"last_updated":"2026-08-25 00:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-06-21/pdf/2016-14627.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-14627.pdf?1466426991","publication_date":"2016-06-21","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2016/06/21/2016-14627.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2016-N-1318","supporting_documents_count":0,"docket_id":"FDA-2016-N-1318","regulation_id_number":null,"title":"Medical Devices; Obstetrical and Gynecological Devices; Classification of the Gynecologic Laparoscopic Power Morcellation Containment System","checked_regulationsdotgov_at":"2016-07-11T19:34:55Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":40181,"subtype":null,"title":"Medical Devices; Obstetrical and Gynecological Devices; Classification of the Gynecologic Laparoscopic Power Morcellation Containment System","toc_doc":"Obstetrical and Gynecological Devices; Classification of the Gynecologic Laparoscopic Power Morcellation Containment System","toc_subject":"Medical Devices:","topics":["Medical devices"],"type":"Rule","volume":81}