# K240002: G-Vitri™ Vitrification Straw

- Pathway: 510(k) (Traditional)
- Applicant: Gimbo Medical Technology Shenzhen Co., Ltd.
- Decided: Jun 14, 2024 after 164 days
- Product code: MQK (Labware, Assisted Reproduction)
- Device class: 2
- Regulation: 21 CFR 884.6160
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The G-Vitri™ Vitrification Straw is a cryopreservation storage device intended for use in vitrification procedures to contain and maintain human oocytes (MII), 4-8 cell embryos, and blastocyst stage embryos.

Source page: https://510kreport.com/device/K240002
Methodology: https://510kreport.com/methodology