# K994417: Ovum Pick-UP Needles with AQ Coating, Aspiration Needles with AQ Coating

- Pathway: 510(k) (Traditional)
- Applicant: Cook Urological, Inc.
- Decided: Mar 1, 2000 after 63 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.
No later device cites it as a predicate yet.
0 of 1 device 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) Cook OB/GYN Ovum Pick-Up Needles: named in the summary without a submission number
- (no number) Aspiration Needles: named in the summary without a submission number
- (no number) Hydrophilic Stents: named in the summary without a submission number
- (no number) Hydrophilic Dilators: named in the summary without a submission number
- (no number) Hydrophilic catheters: named in the summary without a submission number

## Indications for use
The Aspiration/Ovum Pick-Up Aspiration Needles with AQ Coating are used for general irrigation/aspiration and flushing of cocytes from ovarian follicles.

Source page: https://510kreport.com/device/K994417
Methodology: https://510kreport.com/methodology