# K141365: Otrieva Tapered Ovum Aspiration Needle Single Lumen

- Pathway: 510(k) (Special)
- Applicant: William A. Cook Australia Pty., Ltd.
- Decided: Aug 7, 2014 after 76 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 Cook Otrieva™ Tapered Ovum Aspiration Needles are used for laproscopic or ultrasound guided transvaginal aspiration and flushing of oocytes from ovarian follicles.

Source page: https://510kreport.com/device/K141365
Methodology: https://510kreport.com/methodology