K242002
- 510(k) number
- K242002
- Device name
- FemVue MINI Saline-Air Device
- Applicant
- Femasys, Inc. GA · US
- Product code
- LKF — Cannula, Manipulator/Injector, Uterine
- Decision date
- 2024-11-22
- Date received
- 2024-07-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K242002.pdf
Official FDA record: K242002
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.