# K191291: Wallace Dual Lumen Oocyte Recovery System

- Pathway: 510(k) (Special)
- Applicant: CooperSurgical, Inc.
- Decided: Jun 12, 2019 after 29 days
- Product code: MQE (Needle, Assisted Reproduction)
- Device class: 2
- Regulation: 21 CFR 884.6100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K983593 (1999). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182959: Wallace Dual Lumen Oocyte Recovery System, CooperSurgical, Inc. (2019) Summary page 4.

## Most influential descendants
- K232163: Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle (2024), 0 descendants of its own

## Indications for use
The Wallace Dual Lumen Oocyte Recovery System is a sterile, single-use device for ultrasonic-guided transvaginal collection of oocytes from the ovarian follicles.

Source page: https://510kreport.com/device/K191291
Methodology: https://510kreport.com/methodology