510(k) K252260
K252260 is an FDA 510(k) premarket notification submitted by Li Medical Corporation , Ltd. for the device "RELIEEV HSG Catheter (HSG7FA1)". The FDA issued a decision of Substantially Equivalent on November 26, 2025. 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
- November 26, 2025
- Date Received
- July 21, 2025
- 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