Optilume Basic Urological Balloon Dilation Catheter— 510(k) K191061

Name: FDA 510(k) clearance K191061
Creator: U.S. Food and Drug Administration
Published: 2020-01-02

Substantially Equivalent

Urotronic, Inc.

FDA 510(k) clearance K191061 for Optilume Basic Urological Balloon Dilation Catheter, Substantially Equivalent on 2020-01-02. Applicant: Urotronic, Inc.. Device class: 2.

Clearance details

Applicant: Urotronic, Inc.
Product code: Code KOE
Device class: Class 2
Regulation: 21 CFR 876.5520
Advisory panel: Gastroenterology, Urology
Date received: 2019-04-22
Decision date: 2020-01-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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