DeviceClearance

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

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..

Clearance details

Applicant
Urotronic, Inc.
Product code
Code KOE
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Minneapolis, MN, US
Download summary PDFView on FDA.gov ↗

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