510(k) K240364
K240364 is an FDA 510(k) premarket notification submitted by Li Medical Corporation , Ltd. for the device "RELIEEV Uterine Manipulator Injector (CUMI 5.0)". The FDA issued a decision of Substantially Equivalent on October 16, 2024. The device falls under product code LKF (Cannula, Manipulator/Injector, Uterine), a Class II device regulated under 21 CFR 884.4530. Li Medical Corporation , Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 16, 2024
- Date Received
- February 6, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cannula, Manipulator/Injector, Uterine
- Device Class
- Class II
- Regulation Number
- 884.4530
- Review Panel
- OB
- Submission Type