# K181431: Laser Ureteral Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Jul 30, 2018 after 59 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- 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 K960768 (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)
- K960768: Laser Fiber Delivery/Cleaning Catheter, Cook Urological, Inc. (1996) Summary page 4.

## Indications for use
The Laser Ureteral Catheter is intended for protection and delivery of a laser fiber in the urinary tract.

Source page: https://510kreport.com/device/K181431
Methodology: https://510kreport.com/methodology