K233548
- 510(k) number
- K233548
- Device name
- Uresta®
- Applicant
- Resilia, Inc. CA
- Product code
- HHW — Pessary, Vaginal
- Decision date
- 2024-04-03
- Date received
- 2023-11-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
510(k) Summary (official FDA PDF): K233548.pdf
Official FDA record: K233548
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.