HGK · Endoscope, Fetal Blood Sampling (And Accessories)
Obstetrics/Gynecology · 21 CFR 884.1660 · Class 2
Overview
| Product Code | HGK |
|---|---|
| Device Name | Endoscope, Fetal Blood Sampling (And Accessories) |
| Regulation | 21 CFR 884.1660 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
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).
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K954982 | KSEA SCALP BLOOD COLLECTION SET | KARL STORZ Endoscopy-America, Inc. | Jul 17, 1996 | SESE |
Top Applicants
- KARL STORZ Endoscopy-America, Inc. — 1 clearance
