# K962004: AQ Hydrophilic Urological Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Cook Urological, Inc.
- Decided: Jun 11, 1996 after 20 days
- Product code: EYB (Catheter, Ureteral, Gastro-Urology)
- Device class: 2
- Regulation: 21 CFR 876.5130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite 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)
- None. The FDA summary names its predicate without a number.
- (no number) Ship-Coat™ Catheters: named in the summary without a submission number
- (no number) uncoated urological catheters: named in the summary without a submission number

## Most influential descendants
- K171043: Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters (2017), 2 descendants of its own
- K182122: Ureteric Catheters (2018), 1 descendant of its own
- K192183: RocaTub Ureteral Catheter (2020), 0 descendants of its own
- K182695: Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter (2019), 0 descendants of its own

## Indications for use
The AQ Hydrophilic Urological Catheters are intended for drainage, irrigation and/or retrograde pyelogram.

Source page: https://510kreport.com/device/K962004
Methodology: https://510kreport.com/methodology