K240364
- 510(k) number
- K240364
- Device name
- RELIEEV Uterine Manipulator Injector (CUMI 5.0)
- Applicant
- Li Medical Corporation , Ltd. TW
- Product code
- LKF — Cannula, Manipulator/Injector, Uterine
- Decision date
- 2024-10-16
- Date received
- 2024-02-06
- 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: K240364.pdf
Official FDA record: K240364
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.