Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030244515

FEI Number

3030244515

Entity Name

I/O UROLOGY CORPORATION

City/State/Country

Knoxville, TN, US

Establishment Address

1600 Accelerator Way, Ste 360, Knoxville, TN 37920, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

I/O Urology Corporation (Owner Number: 10089587)

Owner / Operator Contact Address

1600 Accelerator Way, Ste 360, Knoxville, TN 37920, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CarePath

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EXY	Uroflowmeter	Gastroenterology, Urology	Class 2	876.1800	2023-12-20

Official Correspondent

Ryan Willemsen

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

I/O Urology Corporation

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3021192255	FIZE Medical LTD.	Modiin Central, IL
3029753827	BRIGHT URO, INC.	Irvine, CA, US
3020978007	DONGGUAN BAO KANG DIAN ZI KE JI LIMITED	Dongguan City Guangdong, CN
3011383638	POTRERO MEDICAL, INC.	Hayward, CA, US
3031976597	Nextern	Maple Grove, MN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030244515. Last updated year: 2026. Please use registration number 3030244515 when referencing this establishment in official correspondence.