510(k) K221086
K221086 is an FDA 510(k) premarket notification submitted by Tmrw Life Sciences, Inc. for the device "CryoRobot Select System". The FDA issued a decision of Substantially Equivalent on November 4, 2022. The device falls under product code QUJ (Automated Cryopreservation Storage System), a Class II device regulated under 21 CFR 884.6120.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 4, 2022
- Date Received
- April 13, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Automated Cryopreservation Storage System
- Device Class
- Class II
- Regulation Number
- 884.6120
- Review Panel
- OB
- Submission Type
To provide an automated liquid nitrogen storage system for oocytes, embryos, and sperm.