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FDA 510(k)

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

K-Number: K261670 · 2026-10-23

ApplicantPoly Medicure Limited
Decision Date2026-10-23
Product CodeLJH
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

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 is the device name listed in this FDA 510(k) record. The listed applicant is Poly Medicure Limited. It received FDA 510(k) clearance on 2026-10-23 under 510(k) number K261670. The device is classified under product code LJH. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 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?

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 is a medical device that received FDA 510(k) clearance on 2026-10-23. The listed applicant is Poly Medicure Limited. The 510(k) number is K261670.

When did 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 receive FDA 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 received FDA 510(k) clearance on 2026-10-23, under 510(k) number K261670.

Who is the listed applicant for 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?

The FDA 510(k) record lists Poly Medicure Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 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?

The FDA product code for 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 is LJH.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: LJH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254111Irrigation/Urology SetsB.Braun Medical, Inc.K162992Karl Storz UROMAT E.A.S.I.Karl Storz Endoscopy America, Inc.K070873AMSURE BLADDER IRRIGATION SETAmsino Intl., Inc.K071832MODIFCATION TO: SPYGLASS IRRIGATION SYSTEMMedical Scientific, Inc.K063700SPYGLASS IRRIGATION SYSTEMMedical Scientific, Inc.K062551NEXUS IRRIGATION TUBING SETNexus Medical, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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