Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Urotronic, Inc.. It received FDA 510(k) clearance on 2020-01-02 under approval 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. It is manufactured by Urotronic, Inc.. The 510(k) number is K191061.

When was Optilume Basic Urological Balloon Dilation Catheter approved by the FDA?

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

What company makes Optilume Basic Urological Balloon Dilation Catheter?

Optilume Basic Urological Balloon Dilation Catheter is manufactured by Urotronic, Inc..

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

NCT05147363 Shockwave: Disruption for A Better Fit WITHDRAWN NCT04647253 A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR) ACTIVE_NOT_RECRUITING NCT06492174 A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR) - Long Lesion Cohort ACTIVE_NOT_RECRUITING NCT07214948 Open, Randomized Feasibility Trial on the Safety and Performance of the INGA Catheter for Labor Induction NOT_YET_RECRUITING NCT07414771 Safety and Usability of the Inga Catheter for Labor Induction (INGA-MDP) NOT_YET_RECRUITING NCT07599826 Active vs. Passive VR During Office-based ENT Procedures NOT_YET_RECRUITING

Other Devices by Urotronic, Inc.

K250910Optilume® High Pressure Urological Balloon Dilation Catheter PMA P210020Catheter, Balloon, Urethral, Drug-Coated PMA P220029Drug coated prostatic dilation catheter for benign prostatic hyperplasia

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.

↑