FDA 510(k)

Optilume® High Pressure Urological Balloon Dilation Catheter

K号: K250910 · 2025-05-22

决定日期2025-05-22

产品代码EZN

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决定实质等同

器械摘要

Optilume® High Pressure Urological Balloon Dilation Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Urotronic, Inc.. It received FDA 510(k) clearance on 2025-05-22 under 510(k) number K250910. The device is classified under product code EZN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Optilume® High Pressure Urological Balloon Dilation Catheter?

Optilume® High Pressure Urological Balloon Dilation Catheter is a medical device that received FDA 510(k) clearance on 2025-05-22. The listed applicant is Urotronic, Inc.. The 510(k) number is K250910.

When did Optilume® High Pressure Urological Balloon Dilation Catheter receive FDA 510(k) clearance?

Optilume® High Pressure Urological Balloon Dilation Catheter received FDA 510(k) clearance on 2025-05-22, under 510(k) number K250910.

Who is the listed applicant for Optilume® High Pressure Urological Balloon Dilation Catheter?

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

What is the FDA product code for Optilume® High Pressure Urological Balloon Dilation Catheter?

The FDA product code for Optilume® High Pressure Urological Balloon Dilation Catheter is EZN.

列明Urotronic, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K191061Optilume Basic Urological Balloon Dilation Catheter

相关器械（代码：EZN）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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官方来源

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