Manufacturer
Cook IncorporatedLaser Ureteral Catheter
Country / Region:United States (US)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
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