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FDA 510(k)

Liv Pre-lubricated Intermittent Catheter

K-Number: K260502 · 2026-03-12

ApplicantHR Healthcare
Decision Date2026-03-12
Product CodeEZD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Liv Pre-lubricated Intermittent Catheter is the device name listed in this FDA 510(k) record. The listed applicant is HR Healthcare. It received FDA 510(k) clearance on 2026-03-12 under 510(k) number K260502. The device is classified under product code EZD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Liv Pre-lubricated Intermittent Catheter?

Liv Pre-lubricated Intermittent Catheter is a medical device that received FDA 510(k) clearance on 2026-03-12. The listed applicant is HR Healthcare. The 510(k) number is K260502.

When did Liv Pre-lubricated Intermittent Catheter receive FDA 510(k) clearance?

Liv Pre-lubricated Intermittent Catheter received FDA 510(k) clearance on 2026-03-12, under 510(k) number K260502.

Who is the listed applicant for Liv Pre-lubricated Intermittent Catheter?

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

What is the FDA product code for Liv Pre-lubricated Intermittent Catheter?

The FDA product code for Liv Pre-lubricated Intermittent Catheter is EZD.

Other records listing HR Healthcare as applicant

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.

K251274EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic Closed System Intermittent Catheter Kits

Related Devices (Code: EZD)

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.

K260737Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Straight (CH06 - CH18); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Coude (CH10 - CH18).ConvatecK261658LoFric Origo Pro CoudéWellspect ABK262045Luja SoftColoplast A.S.K260394Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR)Hangzhou Jimushi Meditech Co., Ltd.K253295Coude Sleeved IC; Coude Plus Sleeved ICHollister IncorporatedK260999LoFric Elle ProWellspect AB

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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