Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013024191

FEI Number

3013024191

Entity Name

UROGEN PHARMA LTD.

City/State/Country

Ra'anana Central, IL

Establishment Address

9 Ha'Ta'asiya Street, Ra'anana Central 4365007, IL

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Urogen Pharma Ltd. (Owner Number: 10055966)

Owner / Operator Contact Address

400 Alexander Park Drive, Princeton, NJ 08540, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K211032

PMA Number

N/A

All Registered Proprietary Names

Uroject12 Syringe Lever UroGen Ureteral Catheter Ureteral Catheter Administration Kit Intravesical Administation Kit Chilling Block Urogen Universal Chilling Block UroGen Urinary Catheter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QBL	Piston Syringe Lever	General Hospital	Class 2	880.5860	2018-10-31
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2018-10-31
OHR	Catheter Care Tray	Gastroenterology, Urology	Class 2	876.5130	2020-05-12
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2017-10-24
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2022-05-17
EZC	Catheter, Coude	Gastroenterology, Urology	Class 2	876.5130	2022-05-17

Official Correspondent

James Ottinger

US Agent Details

James Ottinger Business: Urogen Pharma Inc. Email: jim.ottinger@urogen.com Phone: (610) 7451230

Related Public Records

Same Entity

Urogen Pharma Ltd.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K033719	C.R. Bard, Inc.	BARD TIGERTAIL URETERAL CATHETER	2004-02-04
K820239	American Endoscopy, Inc.	RETRIEVAL FORCEPS	1982-03-26
K041243	Tyco Healthcare	DOVER RED RUBBER ROBINSON CATHETER	2004-07-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2013	C.R. Bard, Inc., Urological Division	2	8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon. The product is packaged individually with 12 units per corrugated case. The product is sold sterile for single use and is used to provide continuous urinary drainage from the bladder.
Z-0002-2008	Beckman Coulter Inc	1	FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013	Biomerieux Inc	1	PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.

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3009504230	Sterigenics Radiation Technologies IN, Inc	Columbia City, IN, US
3007829657	ROBLING MEDICAL, LLC	Youngsville, NC, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013024191. Last updated year: 2026. Please use registration number 3013024191 when referencing this establishment in official correspondence.