K253403
- 510(k) number
- K253403
- Device name
- FemVue® Controlled Saline-Air Device (FSA-300)
- Applicant
- Femasys, Inc. GA · US
- Product code
- LKF — Cannula, Manipulator/Injector, Uterine
- Decision date
- 2025-12-15
- Date received
- 2025-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K253403.pdf
Official FDA record: K253403
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.