K221810 is an FDA 510(k) clearance for the LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device. This device is classified as a Labware, Assisted Reproduction (Class II - Special Controls, product code MQK).
Submitted by Bonraybio Co., Ltd. (Taichung, TW). The FDA issued a Cleared decision on October 31, 2022, 131 days after receiving the submission on June 22, 2022.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.6160.
| 510(k) Number | K221810 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 22, 2022 |
| Decision Date | October 31, 2022 |
| Days to Decision | 131 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | MQK - Labware, Assisted Reproduction |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.6160 |