PELVX GELLHORN VAGINAL PESSARY 603-608
Device Facts
| Record ID | K002329 |
|---|---|
| Device Name | PELVX GELLHORN VAGINAL PESSARY 603-608 |
| Applicant | Deschutes Medical Products, Inc. |
| Product Code | HHW · Obstetrics/Gynecology |
| Decision Date | Sep 18, 2000 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.3575 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A vaginal pessary is a removable structure placed in the vagina to support the pelvic organs and is used to treat conditions such as uterine prolapse (falling down of uterus), uterine retroposition (backward displacement), or gynecologic hernia.
