# K182695: Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Jun 17, 2019 after 263 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
Longest line of descent: 1 generation back to K962004 (1996). 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)
- K962004: AQ Hydrophilic Urological Catheters, Cook Urological, Inc. (1996) Summary page 4.

## Indications for use
Indicated for drainage or irrigation in the urinary tract as well as access, advancement or exchange of wire guides.

Source page: https://510kreport.com/device/K182695
Methodology: https://510kreport.com/methodology