VAGINAL CONTINENCE DEVICE
Device Facts
| Record ID | K930618 |
|---|---|
| Device Name | VAGINAL CONTINENCE DEVICE |
| Applicant | Johnson & Johnson Medical, Inc. |
| Product Code | HHW · Obstetrics/Gynecology |
| Decision Date | May 4, 1995 |
| 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.
