GENXCATHETER
Device Facts
| Record ID | K963031 |
|---|---|
| Device Name | GENXCATHETER |
| Applicant | Genx Intl., Inc. |
| Product Code | MFD · Obstetrics/Gynecology |
| Decision Date | Oct 21, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.5250 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A cervical cap is a flexible cuplike receptacle that fits over the cervix to collect menstrual flow or to aid artificial insemination. This generic type of device is not for contraceptive use.