K241693
- 510(k) number
- K241693
- Device name
- FemChec Controlled Saline-Air Device (FCD-250)
- Applicant
- Femasys, Inc. GA · US
- Product code
- LKF — Cannula, Manipulator/Injector, Uterine
- Decision date
- 2024-09-06
- Date received
- 2024-06-12
- 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: K241693.pdf
Official FDA record: K241693
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.