Clearance Summary
CIMILRE Free-T2 Plus received FDA 510(k) clearance under submission number K221708, sponsored by Cimilre Co., 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 2022-12-23.
- Submission: K221708
- Applicant / Sponsor: Cimilre Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5160
- Decision date: 2022-12-23
Classification & Regulation
This clearance is catalogued under FDA product code HGX and 21 CFR 884.5160, within the Obstetrics/Gynecology review panel as a Class II device.