510(k) clearance
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
- 510(k) number
- K261670
- Applicant
- Poly Medicure Limited
- Decision date
- Oct 23, 2026
- Date received
- May 20, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- LJH
- Device type
- System, Irrigation, Urological
- Device class
- Class II
- Regulation
- 21 CFR 876.5130
- Advisory committee
- Gastroenterology, Urology
- Statement or summary
- Summary
- Third party
- N
- Location
- Jaipur, IN