Cleared Traditional

Optilume? High Pressure Urological Balloon Dilation Catheter

K250910 · Urotronic, Inc. · Gastroenterology & Urology
May 2025
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K250910 is an FDA 510(k) clearance for the Optilume? High Pressure Urological Balloon Dilation Catheter, a Dilator, Catheter, Ureteral (Class II — Special Controls, product code EZN), submitted by Urotronic, Inc. (Minneapolis, US). The FDA issued a Cleared decision on May 22, 2025, 57 days after receiving the submission on March 26, 2025. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5470.

Submission Details

510(k) Number K250910 FDA.gov
FDA Decision Cleared SESE
Date Received March 26, 2025
Decision Date May 22, 2025
Days to Decision 57 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code EZN — Dilator, Catheter, Ureteral
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5470

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