# K012068: Wallace Oocyte Retrieval Sets 16G, Wallace Oocyte Retrieval Set 17G, Models Meons 1633S, Meons 1733S

- Pathway: 510(k) (Traditional)
- Applicant: Sims Portex, Ltd.
- Decided: Aug 3, 2001 after 32 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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 no predicate by number.

## Most influential descendants
- K023930: Coopersurgical Oocyte Recovery Needles (2003), 0 descendants of its own

## 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.

## Indications for use
The Wallace Oocyte Retrieval Sets are sterile, single-use devices intended for ultrasound-guided, transvaginal collection of oocytes for ovarian follicles.

Source page: https://510kreport.com/device/K012068
Methodology: https://510kreport.com/methodology