ClearanceBrief
510(k) K261670 ยท LJH System, Irrigation, Urological

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

ApplicantPoly Medicure Limited, Jaipur, IN
DecisionSubstantially Equivalent, Oct 23, 2026
ReceivedMay 20, 2026
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K261670

No recall in the FDA data names this 510(k).

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.