part_subject: "OBSTETRICAL AND GYNECOLOGICAL DEVICES"
subpart_code: "B"
subpart_subject: "Obstetrical and Gynecological Diagnostic Devices"
section_number: "884.1175"
section_subject: "Endometrial suction curette and accessories."
cfr_reference: "21 CFR 884.1175"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 800 to 1299"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
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(a)Identification. An endometrial suction curette is a device used to remove material from the uterus and from the mucosal lining of the uterus by scraping and vacuum suction. This device is used to obtain tissue for biopsy or for menstrual extraction. This generic type of device may include catheters, syringes, and tissue filters or traps.
(b)Classification. Class II (performance standards).