Benchmed logo
Benchmed

Laser Ureteral Catheter

Cook Incorporated

Country / region:United States (US)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

View Summary PDF

Company

Cook Incorporated
United States (US)

Product code

GEX
21 CFR 878.4810

Predicate devices

2
View list →

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K181431
Device name
Laser Ureteral Catheter
Company
Cook Incorporated
Country / region
United States(US)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2018-06-01
Decision date
2018-07-30
Submission type
Traditional
Technology type
Other(AI inferred)
Clinical applications
Surgical cutting
Primary application
Surgical cutting
Classification source
AI classified

Indications for Use

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

Intended Use

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

Device Description

The Laser Ureteral Catheter is a single lumen catheter available in a diameter of 7.1 French and a length of 40 centimeters. The Laser Ureteral Catheter is manufactured from polyethylene tubing, with a proximal female Luer lock adapter and connector cap, and male Luer lock adapter and connector cap with a cap seal. The device is provided sterile and intended for one-time use.

Summary parsed at:2026-06-01 05:57:37 UTC

Predicate devices

2

K181431 references 2 predicate/reference devices

Cited as predicate

0

No later 510(k)s cite this device yet

Other submissions will appear here when they list K181431 as a predicate