# K983593: Ovum Pick-UP Aspiration Needles

- Pathway: 510(k) (Traditional)
- Applicant: Cook Ob/Gyn
- Decided: Jan 21, 1999 after 100 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
No predicates in its family tree.
8 later devices descend from it; 5 cite it directly.
0 of 9 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 its predicate without a number.
- (no number) Ovum Pick-Up Aspiration Needles manufactured by Cook Australia: named in the summary without a submission number

## Most influential descendants
- K031622: Wallace Dual Lumen Oocyte Retrieval Sets (2003), 3 descendants of its own
- K182959: Wallace Dual Lumen Oocyte Recovery System (2019), 2 descendants of its own
- K191291: Wallace Dual Lumen Oocyte Recovery System (2019), 1 descendant of its own
- K240523: VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G) (2024), 0 descendants of its own
- K232163: Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle (2024), 0 descendants of its own

## Indications for use
The Ovum Pick-Up Aspiration Needles are used for aspiration and flushing of oocytes from ovarian follicles.

Source page: https://510kreport.com/device/K983593
Methodology: https://510kreport.com/methodology