CryoX Vitrification Freeze Kit / Thaw Kit (K223265)
Description
CryoX Vitrification Freeze Kit / Thaw Kit by Zhejiang Horizon Medical Technology Co., Ltd., an FDA 510(k) cleared obstetrics/gynecology device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223265
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. CryoX Vitrification Freeze Kit / Thaw Kit (K223265) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K190152 | Vit Kit- Freeze NX and Vit Kit- Warm NX | Fujifilm Irvine Scientific, Inc. | 2019 |
Trace the full predicate network for K223265
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.