510(k) K261670

Device

Polymed TUR Irrigation Set, Single Spike, Tubing 90 with Luer Lock - Sterile (30031 ); Polymed TUR Irrigation Set, Y-Type, 2 Leads, Tubing 90 with Luer Lock - Sterile (30032); Polymed TUR Irrigation Set, Y-Type, 4 Leads, Tubing, 90 with Luer Lock- Sterile (30033); Polymed TUR Irrigation Set, Single Spike, Tubing 80, with Luer Lock - Sterile (30034); Polymed TUR Irrigation Set, Y-Type, 2 Leads, Tubing 80, with Luer Lock- Sterile (30035); Polymed TUR Irrigation Set, Y- Type, 4 Leads

Applicant

Poly Medicure Limited

510(k) number

K261670

Product code

LJH

Decision

Substantially Equivalent (SESE)

Decision date

2026-10-23

Date received

2026-05-20

Regulation

876.5130

Classification name

System, Irrigation, Urological

Medical specialty

Gastroenterology, Urology

Review panel

Gastroenterology, Urology

Device class

2

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

N