21 CFR 884.5070 — Source, Abortion Unit, Vacuum
Obstetrics/Gynecology (OB) · Part 884 Subpart F—Obstetrical and Gynecological Therapeutic Devices · § 884.5070
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).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HGF | Source, Abortion Unit, Vacuum | 2 | 4 | 3rd Party |
| HGG | Controller, Abortion Unit, Vacuum | 2 | 1 | 3rd Party |
| HGH | Cannula, Suction, Uterine | 2 | 6 | 3rd Party |
| HHI | System, Abortion, Vacuum | 2 | 24 | 3rd Party |
