HGG · Controller, Abortion Unit, Vacuum
Obstetrics/Gynecology · 21 CFR 884.5070 · Class 2
Overview
| Product Code | HGG |
|---|---|
| Device Name | Controller, Abortion Unit, Vacuum |
| Regulation | 21 CFR 884.5070 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
| 3rd-Party Reviewable | Yes |
Identification
A vacuum abortion system is a device designed to aspirate transcervically the products of conception or menstruation from the uterus by using a cannula connected to a suction source. This device is used for pregnancy termination or menstrual regulation. This type of device may include aspiration cannula, vacuum source, and vacuum controller.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K883283 | DISPOSABLE AMNIOTOME | Galenica Enterprises, Inc. | Oct 18, 1988 | SESE |
Top Applicants
- Galenica Enterprises, Inc. — 1 clearance
