K231786
- 510(k) number
- K231786
- Device name
- Gynethotics Pessary
- Applicant
- Cosm Medical CA
- Product code
- HHW — Pessary, Vaginal
- Decision date
- 2024-03-06
- Date received
- 2023-06-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K231786.pdf
Official FDA record: K231786
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.