Clearance Summary
RELIEEV Suction Curette (Flexible 3.0/ Standard 3.6) received FDA 510(k) clearance under submission number K240434, sponsored by Li Medical Corporation , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2024-09-25.
- Submission: K240434
- Applicant / Sponsor: Li Medical Corporation , Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1175
- Decision date: 2024-09-25
Classification & Regulation
This clearance is catalogued under FDA product code HHK and 21 CFR 884.1175, within the Obstetrics/Gynecology review panel as a Class II device.