# K234023: Oocyte Flushing & Retrieval Medium; Gamete Buffer

- Pathway: 510(k) (Traditional)
- Applicant: Gimbo Medical Technology Shenzhen Co., Ltd.
- Decided: May 10, 2024 after 142 days
- Product code: MQL (Media, Reproductive)
- Device class: 2
- Regulation: 21 CFR 884.6180
- 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
Oocyte Flushing & Retrieval Medium is intended for use during ovarian follicle flushing and oocyte collection procedures for use in in vitro fertilization procedures. Gamete Buffer is indicated for use in short-term handling and manipulating gametes and embryos, including washing and intracytoplasmic sperm injection (ICSI).

Source page: https://510kreport.com/device/K234023
Methodology: https://510kreport.com/methodology