# K000628: Wallace Oocyte Retrieval Set-16G, Model MEONS1633; Wallace Oocyte Retrieval Set-17G, Model MEONS1733

- Pathway: 510(k) (Traditional)
- Applicant: Sims Portex, Ltd.
- Decided: Mar 13, 2000 after 18 days
- Product code: MQE (Needle, Assisted Reproduction)
- Device class: 2
- Regulation: 21 CFR 884.6100
- Recalls of this device: 1 (0 Class I)
- 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 has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Oct 23, 2008 · Not classified · Z-0593-2009: Smiths Medical International became aware that certain lots of Wallace oocyte Recovery Sets have a damaged needle tip.

Source page: https://510kreport.com/device/K000628
Methodology: https://510kreport.com/methodology