# 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, Sin

**Predicate Speed & CAPA Advisory Opportunity Score:** 54/100

| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | 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 |
| Specialty / panel | Gastroenterology, Urology |
| Product code | LJH |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-05-20 |
| Decision date | 2026-10-23 |
| Review time (days) | 156 |
| Third-party review | No |
| Applicant location | Jaipur, IN |

## Why this score
- 156-day review, longer than typical.
- Posted 12 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261670). Last refreshed: 2026-11-04T09:16:12.111Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.