21 CFR 884.1660 — Endoscope, Transcervical (Amnioscope)(And Accessories)
Obstetrics/Gynecology (OB) · Part 884 Subpart B—Obstetrical and Gynecological Diagnostic Devices · § 884.1660
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.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HEZ | Endoscope, Transcervical (Amnioscope)(And Accessories) | 2 | 0 | 3rd Party |
| HGK | Endoscope, Fetal Blood Sampling (And Accessories) | 2 | 1 |
