FDA 510(k)

Optilume® High Pressure Urological Balloon Dilation Catheter

K-Number: K250910 · 2025-05-22

Decision Date2025-05-22

Product CodeEZN

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

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.

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. 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.

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.

NCT03499964ROBUST III- Re-Establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture DiseaseACTIVE_NOT_RECRUITING NCT06312722Safety and Effectiveness of the Optilume® BPH Catheter System in a Post-Market StudyRECRUITING NCT04131907Optilume™ BPH Catheter System in Men With Symptomatic BPHACTIVE_NOT_RECRUITING NCT07019623U-CaVIT Versus Standard of Care for Prevention of Atonic Postpartum Hemorrhage After Cesarean Section in High-risk Women.RECRUITING NCT05805280IntravasCular Imaging-Guided Versus AngiogRaphy-GUided Drug-Eluting Stent Implantation for Fermoropopliteal Artery DiseaseCOMPLETED NCT06297291Global Paradise System US Post Approval StudyRECRUITING

Other records listing Urotronic, Inc. as applicant

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

Related Devices (Code: EZN)

K220781ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator, Glider Amplatz Sheath, ARMADA Renal Dilator with Amplatz Sheath, Fascial Dilator Set, Introducer Sheath, Introducer CatheterAllwin Medical Devices, Inc.K201007In-Ka Ureteral Balloon Dilatation CatheterColoplast Corp.K190612EQUINOX Balloon Dilatation CatheterDornier Medtech America, Inc.K173654Ureteral Dilator Sets, Ureteral DilatorsCook Incorporated K180756Safety Wire Guide IntroducerCook Incorporated K180028Cook 810 Set, Desilets-Hoffman Introducer SetCook Incorporated

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.