Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3024807849

FEI Number

3024807849

Entity Name

THE URETERAL STENT COMPANY, INC.

City/State/Country

Beachwood, OH, US

Establishment Address

23950 Commerce Park Road, Ste 100, Beachwood, OH 44122, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

The Ureteral Stent Company, Inc. (Owner Number: 10086357)

Owner / Operator Contact Address

23950 Commerce Park Road, Suite 100, Beachwood, OH 44122, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K232920

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2022-11-02
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2024-12-04

Official Correspondent

Kevin Mendelsohn

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

The Ureteral Stent Company, Inc.

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0037-2023	Hobbs Medical, Inc.	2	Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6001
Z-0038-2023	Hobbs Medical, Inc.	2	Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number:6004
Z-0039-2023	Hobbs Medical, Inc.	2	Hobbs Biliary Pigtail Stent Kits (containing 6105) Catalog Number: 6023
Z-0040-2023	Hobbs Medical, Inc.	2	Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6024
Z-0041-2023	Hobbs Medical, Inc.	2	Hobbs Biliary Pigtail Stent Kits (contains 3412) Catalog Number: 6027

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3015225571	Merit Medical Asia Company Limited	Tsim Sha Tsui, HK
2126666	Lake Region Medical	CHASKA, MN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3024807849. Last updated year: 2026. Please use registration number 3024807849 when referencing this establishment in official correspondence.