Clearance Summary
LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device received FDA 510(k) clearance under submission number K221810, sponsored by Bonraybio 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 2022-10-31.
- Submission: K221810
- Applicant / Sponsor: Bonraybio Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.6160
- Decision date: 2022-10-31
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.