# K023850: Sydney Ivf Embryo Biopsy Medium

- Pathway: 510(k) (Traditional)
- Applicant: Cook Ob/Gyn
- Decided: Jan 22, 2003 after 64 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) 63 FR 48428, September 10, 1998: named in the summary without a submission number

## Most influential descendants
- K152904: Sydney Ivf Embryo Biopsy Medium (2015), 0 descendants of its own
- K060983: Biopsy Medium, Model Ref 1062 (2006), 0 descendants of its own

## Indications for use
Sydney IVF Embryo Biopsy Medium is intended for use in assisted reproduction technologies to facilitate the aspiration of blastomeres for pre-implantation genetic diagnosis.

Source page: https://510kreport.com/device/K023850
Methodology: https://510kreport.com/methodology