K221086 is an FDA 510(k) clearance for the CryoRobot Select System. This device is classified as a Automated Cryopreservation Storage System (Class II - Special Controls, product code QUJ).
Submitted by Tmrw Life Sciences, Inc. (New York, US). The FDA issued a Cleared decision on November 4, 2022, 205 days after receiving the submission on April 13, 2022.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.6120. To Provide An Automated Liquid Nitrogen Storage System For Oocytes, Embryos, And Sperm..
| 510(k) Number | K221086 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 13, 2022 |
| Decision Date | November 04, 2022 |
| Days to Decision | 205 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | QUJ - Automated Cryopreservation Storage System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.6120 |
| Definition | To Provide An Automated Liquid Nitrogen Storage System For Oocytes, Embryos, And Sperm. |