KOLSTER METHODS
Device Facts
| Record ID | K935820 |
|---|---|
| Device Name | KOLSTER METHODS |
| Applicant | Kolster Methods |
| Product Code | HGH · Obstetrics/Gynecology |
| Decision Date | Jul 19, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.5070 |
| Device Class | Class 2 |
Regulatory Classification
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.
