Class Class II
cryo-GO Vitrification Device (K241341)
Description
cryo-GO Vitrification Device by Fujifilm Irvine Scientific, an FDA 510(k) cleared obstetrics/gynecology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241341
Clearance Date2024-09-26
Clearance TypeTraditional
Product CodeMQK
Regulation Number884.6160
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241341
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. cryo-GO Vitrification Device (K241341) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K200815 | VitriGuard | Origio A/S | 2020 |
Trace the full predicate network for K241341
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.