DeviceClearance

Product code QUJ— Obstetrics/Gynecology

CryoRobot Select System

Classification name
Automated Cryopreservation Storage System
Device class
Class 2
Regulation
21 CFR 884.6120
Advisory panel
Obstetrics/Gynecology
Total cleared
1
First cleared
Most recent

FDA classification definition

“To provide an automated liquid nitrogen storage system for oocytes, embryos, and sperm.”

— U.S. Food and Drug Administration, device classification record for product code QUJ under 21 CFR 884.6120, via openFDA

Market context for product code QUJ

FDA has cleared 1 device under product code QUJ, all in 2022, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QUJ

Recent clearances under product code QUJ

Data sourced from openFDA. This site is unofficial and independent of the FDA.