# K261670: 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

- Pathway: 510(k) (Traditional)
- Applicant: Poly Medicure Limited
- Decided: Oct 23, 2026 after 156 days
- Product code: LJH (System, Irrigation, Urological)
- Device class: 2
- Regulation: 21 CFR 876.5130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

Source page: https://510kreport.com/device/K261670
Methodology: https://510kreport.com/methodology