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FDA 510(k)

Optilume® High Pressure Urological Balloon Dilation Catheter

K-Number: K250910 · 2025-05-22

ApplicantUrotronic, Inc.
Decision Date2025-05-22
Product CodeEZN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Urotronic, Inc.. The 510(k) number is K250910.

When was Optilume® High Pressure Urological Balloon Dilation Catheter approved by the FDA?

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

What company makes Optilume® High Pressure Urological Balloon Dilation Catheter?

Optilume® High Pressure Urological Balloon Dilation Catheter is manufactured by Urotronic, Inc..

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.

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Other Devices by Urotronic, Inc.

K191061Optilume Basic Urological Balloon Dilation Catheter PMA P210020Catheter, Balloon, Urethral, Drug-Coated PMA P220029Drug coated prostatic dilation catheter for benign prostatic hyperplasia

Related Devices (Code: EZN)

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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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