HFA · Amnioscope, Transabdominal (Fetoscope) (And Accessories)
Obstetrics/Gynecology · 21 CFR 884.1600 · Class f
Overview
| Product Code | HFA |
|---|---|
| Device Name | Amnioscope, Transabdominal (Fetoscope) (And Accessories) |
| Regulation | 21 CFR 884.1600 |
| Device Class | Class f |
| Review Panel | Obstetrics/Gynecology |
Identification
A transabdominal amnioscope is a device designed to permit direct visual examination of the fetus by a telescopic system via abdominal entry. The device is used to ascertain fetal abnormalities, to obtain fetal blood samples, or to obtain fetal tissue. This generic type of device may include the following accessories: trocar and cannula, instruments used through an operating channel or through a separate cannula associated with the amnioscope, light source and cables, and component parts.
Classification Rationale
Class III (premarket approval).
Recent Cleared Devices (0 of 0)
No cleared devices on record.
