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FDA 510(k)

Optilume Basic Urological Balloon Dilation Catheter

K-Number: K191061 · 2020-01-02

ApplicantUrotronic, Inc.
Decision Date2020-01-02
Product CodeKOE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Optilume Basic 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 2020-01-02 under 510(k) number K191061. The device is classified under product code KOE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Optilume Basic Urological Balloon Dilation Catheter?

Optilume Basic Urological Balloon Dilation Catheter is a medical device that received FDA 510(k) clearance on 2020-01-02. The listed applicant is Urotronic, Inc.. The 510(k) number is K191061.

When did Optilume Basic Urological Balloon Dilation Catheter receive FDA 510(k) clearance?

Optilume Basic Urological Balloon Dilation Catheter received FDA 510(k) clearance on 2020-01-02, under 510(k) number K191061.

Who is the listed applicant for Optilume Basic 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 Basic Urological Balloon Dilation Catheter?

The FDA product code for Optilume Basic Urological Balloon Dilation Catheter is KOE.

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_RECRUITINGNCT06312722Safety and Effectiveness of the Optilume® BPH Catheter System in a Post-Market StudyRECRUITINGNCT04131907Optilume™ BPH Catheter System in Men With Symptomatic BPHACTIVE_NOT_RECRUITINGNCT06799052Cervical Preparation for Same-Day Dilation & EvacuationRECRUITINGNCT07019623U-CaVIT Versus Standard of Care for Prevention of Atonic Postpartum Hemorrhage After Cesarean Section in High-risk Women.RECRUITINGNCT07583706A Single-center, Single-arm Study to Evaluate the Safety and Efficacy of Ultra-minimally Invasive Prostate Dilation in Treating Patients With Significant Obstructive Symptoms Caused by Benign Prostatic HyperplasiaRECRUITING

Other records listing Urotronic, Inc. 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.

PMA P220029Drug coated prostatic dilation catheter for benign prostatic hyperplasiaPMA P210020Catheter, Balloon, Urethral, Drug-CoatedK250910Optilume® High Pressure Urological Balloon Dilation Catheter

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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