# K171625: Single Lumen Ovum Aspiration Needles

- Pathway: 510(k) (Special)
- Applicant: Willian A. Cook Australia Pty, Ltd.
- Decided: Jan 12, 2018 after 224 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: 1 generation back to K983593 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983593: Ovum Pick-UP Aspiration Needles, Cook Ob/Gyn (1999) Summary page 4.

## Indications for use
The Single Lumen Ovum Aspiration Needles are used for laparoscopic or ultrasound guided transvaginal aspiration and flushing of oocytes from ovarian follicles for patients undergoing Assisted Reproductive procedures.

Source page: https://510kreport.com/device/K171625
Methodology: https://510kreport.com/methodology