K242089
- 510(k) number
- K242089
- Device name
- Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202)
- Applicant
- Jiangsu Ruifuda Medical Device Co., Ltd. CN
- Product code
- MQL — Media, Reproductive
- Decision date
- 2025-04-10
- Date received
- 2024-07-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K242089.pdf
Official FDA record: K242089
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.