SHOLKOFF BALLOON HYSTEROSALPINGOGRAPHY CATHETER
Device Facts
| Record ID | K891290 |
|---|---|
| Device Name | SHOLKOFF BALLOON HYSTEROSALPINGOGRAPHY CATHETER |
| Applicant | Cook Ob/Gyn |
| Product Code | HES · Obstetrics/Gynecology |
| Decision Date | May 23, 1989 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.1300 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A uterotubal carbon dioxide insufflator and accessories is a device used to test the patency (lack of obstruction) of the fallopian tubes by pressurizing the uterus and fallopian tubes and filling them with carbon dioxide gas.
