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FDA 510(k)

OpenFlo Urinary Catheter

K-Number: K261141 · 2026-10-06

ApplicantUrolution Medical, Inc.
Decision Date2026-10-06
Product CodeEZL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

OpenFlo Urinary Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Urolution Medical, Inc.. It received FDA 510(k) clearance on 2026-10-06 under 510(k) number K261141. The device is classified under product code EZL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OpenFlo Urinary Catheter?

OpenFlo Urinary Catheter is a medical device that received FDA 510(k) clearance on 2026-10-06. The listed applicant is Urolution Medical, Inc.. The 510(k) number is K261141.

When did OpenFlo Urinary Catheter receive FDA 510(k) clearance?

OpenFlo Urinary Catheter received FDA 510(k) clearance on 2026-10-06, under 510(k) number K261141.

Who is the listed applicant for OpenFlo Urinary Catheter?

The FDA 510(k) record lists Urolution Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OpenFlo Urinary Catheter?

The FDA product code for OpenFlo Urinary Catheter is EZL.

Related Clinical Trials

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Related Devices (Code: EZL)

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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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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