part_subject: "OBSTETRICAL AND GYNECOLOGICAL DEVICES"
subpart_code: "B"
subpart_subject: "Obstetrical and Gynecological Diagnostic Devices"
section_number: "884.1660"
section_subject: "Transcervical endoscope (amnioscope) and accessories."
cfr_reference: "21 CFR 884.1660"
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. A transcervical endoscope is a device designed to permit direct viewing of the fetus and amniotic sac by means of an open tube introduced into the uterus through the cervix. The device may be used to visualize the fetus or amniotic fluid and to sample fetal blood or amniotic fluid. This generic type of device may include obturators, instruments used through an operating channel, light sources and cables, and component parts.
(b)Classification. Class II (performance standards).