Code of Federal Regulations Title 21. Food and Drugs § 21.884.1660 Transcervical endoscope (amnioscope) and accessories

(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).