Clearance Summary
SperSort Sperm Sorting Chip (IPG02) received FDA 510(k) clearance under submission number K241626, sponsored by Ipreg Incorporation. 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 2025-02-20.
- Submission: K241626
- Applicant / Sponsor: Ipreg Incorporation
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.6160
- Decision date: 2025-02-20
Classification & Regulation
This clearance is catalogued under FDA product code MQK and 21 CFR 884.6160, within the Obstetrics/Gynecology review panel as a Class II device.