Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015228875

FEI Number

3015228875

Entity Name

UROTRONIC INC

City/State/Country

Plymouth, MN, US

Establishment Address

2495 Xenium Lane North, Plymouth, MN 55441, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Urotronic Inc (Owner Number: 10063084)

Owner / Operator Contact Address

2495 Xenium Lane North, Plymouth, MN 55441, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K191061

PMA Number

N/A

All Registered Proprietary Names

Optilume Basic Urological Balloon Dilation Catheter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KOE	Dilator, Urethral	Gastroenterology, Urology	Class 2	876.5520	2020-03-16

Official Correspondent

Nicole Boser

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Urotronic Inc

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015228875. Last updated year: 2026. Please use registration number 3015228875 when referencing this establishment in official correspondence.