510(k) K221810
K221810 is an FDA 510(k) premarket notification submitted by Bonraybio Co., Ltd. for the device "LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device". The FDA issued a decision of Substantially Equivalent on October 31, 2022. The device falls under product code MQK (Labware, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6160. Bonraybio Co., Ltd. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 31, 2022
- Date Received
- June 22, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Labware, Assisted Reproduction
- Device Class
- Class II
- Regulation Number
- 884.6160
- Review Panel
- OB
- Submission Type