Automated Cryopreservation Storage System
The Automated Cryopreservation Storage System is a device that provides an automated liquid nitrogen storage system for the long-term cryopreservation of oocytes, embryos, and sperm in assisted reproductive technology (ART) settings, managing temperature, inventory tracking, and sample retrieval in an automated fashion. Classified as FDA Class 2 under regulation 884.6120, it is 510(k) exempt but still subject to general controls in the Obstetrics and Gynecology specialty. It is not an implant and not life-sustaining.
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Basic Information
- Product Code
- QUJ
- Device Class
- FDA class 2
- Regulation Number
- 884.6120
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 4
Device Characteristics
Definition
To provide an automated liquid nitrogen storage system for oocytes, embryos, and sperm.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K221086 | CryoRobot Select System | Nov 04, 2022 | Substantially Equivalent | Tmrw Life Sciences, Inc. |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.