Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015042209

FEI Number

3015042209

Entity Name

UROVIU CORPORATION

City/State/Country

Los Altos, CA, US

Establishment Address

4546 El Camino Real, Suite 214, Los Altos, CA 94022, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

UroViu Corporation (Owner Number: 10058555)

Owner / Operator Contact Address

4546 El Camino Real, Suite 214, Los Altos, CA 94022, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K202921

PMA Number

N/A

All Registered Proprietary Names

Uro-V Cystoscope Hystero-V Hystroscope UroViu Drape Uro-N Cystoscope Uro-G HD Flexible Cystoscope UV5000W UroViu Grasper Uro-G Flexible Cystoscope

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2018-10-09
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2022-06-29
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2024-10-22
FBK	Endoscopic Injection Needle, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2021-08-16
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2021-08-16
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2024-12-05
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2026-05-01
PTS	Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt	Gastroenterology, Urology	Class 2	876.1500	2023-08-07
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2021-08-16

Official Correspondent

Thomas Lawson

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

UroViu Corporation

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
K935716	KARL STORZ Endoscopy-America, Inc.	KARL STORZ FIXED MAGNIFICATION TELESCOPE/KS VARIABLE MAGNIFICATION TELESCOPE	1995-11-16

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0020-2023	Hobbs Medical, Inc.	2	Hobbs Posi-Stop Injection Needle Catalog Number: 4702
Z-0021-2023	Hobbs Medical, Inc.	2	Hobbs Posi-Stop Injection Needle Catalog Number: 4704
Z-0022-2023	Hobbs Medical, Inc.	2	Hobbs Posi-Stop Injection Needle Catalog Number: 4712
Z-0023-2023	Hobbs Medical, Inc.	2	Hobbs Posi-Stop Injection Needle Catalog Number: 4718
Z-0024-2023	Hobbs Medical, Inc.	2	Hobbs Posi-Stop Injection Needle Catalog Number: 4720

Similar Registrations

Registration Number	Establishment Name	Location
3012375451	SHERN YEONG PRECISE OPTICAL CO., LTD.	Dongshan Township, Yilan County, TW
9614434	STORZ ENDOSKOP PRODUKTIONS GMBH	SCHAFFHAUSEN, CH
3035710892	Guangdong MacroLux Medical Technology Co., Ltd.	Dongguan Guangdong, CN
3008386005	IAN JAMIESON PTY LTD	Fyshwick Australian Capital Territory, AU
3008837339	STRYKER EMEA Supply Chain Services	Venlo Limburg, NL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015042209. Last updated year: 2026. Please use registration number 3015042209 when referencing this establishment in official correspondence.