K231730
- 510(k) number
- K231730
- Device name
- FemaSeed Intratubal Insemination
- Applicant
- Femasys, Inc. GA · US
- Product code
- MQF — Catheter, Assisted Reproduction
- Decision date
- 2023-09-22
- Date received
- 2023-06-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 2.9 MB · U.S. public domain
Also available from FDA: K231730.pdf
Official FDA record: K231730
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.