Data / Medical devices / United States / Uroviu Corporation

Uroviu Corporation: FDA-registered device maker in Los Altos, CA, United States, 7 510(k) clearances

Name: Uroviu Corporation FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Uroviu Corporation is registered with the FDA (registration 3015042209) in Los Altos, CA, United States. It lists 5 device types. The FDA files 7 510(k) clearances under its listings, the newest dated October 23, 2025. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3015042209
Address: 4546 El Camino Real Suite 214, Los Altos, CA, United States, 94022
Owner or operator: UroViu Corporation (10058555)
Roles: Complaint file establishment, Specification developer
First device listed: October 9, 2018
Registered through: 2026
Brand names listed: Hystero-V Hystroscope, UV5000 Handle, UV5000W, Uro-G Flexible Cystoscope, Uro-G HD Flexible Cystoscope, Uro-N Cystoscope, Uro-V Cystoscope, UroViu Drape and more

Devices it lists

Device	Product code	Class	Role	Source
Cystoscope And Accessories, Flexible/Rigid	FAJ	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Drape, Surgical, Exempt	PUI	2	Specification developer	accessdata.fda.gov
Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt	PTS	2	Specification developer	accessdata.fda.gov
Endoscopic Injection Needle, Gastroenterology-Urology	FBK	2	Specification developer	accessdata.fda.gov
Hysteroscope (And Accessories)	HIH	2	Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
October 23, 2025	K253226	UV5000W Handle	FAJ	Substantially Equivalent	Uroviu Corporation	accessdata.fda.gov
September 11, 2025	K250797	UV5000 Handle	FAJ	Substantially Equivalent	Uroviu Corporation	accessdata.fda.gov
June 7, 2024	K232837	Uro-G HD Flexible Cystoscope	FAJ	Substantially Equivalent	Uroviu Corporation	accessdata.fda.gov
November 23, 2021	K202445	Hystero-V Hysteroscope	HIH	Substantially Equivalent	Hysterovue, Inc.	accessdata.fda.gov
May 4, 2021	K202921	Uro-G Cystoscope	FAJ	Substantially Equivalent	Uroviu Corporation	accessdata.fda.gov
July 2, 2019	K182876	Uro-N Cystoscope	FAJ	Substantially Equivalent	Uroviu Corporation	accessdata.fda.gov
January 30, 2018	K171500	Uro-V Cystoscope	FAJ	Substantially Equivalent	Uroviu Corporation	accessdata.fda.gov

Compare with other makers

Updated October 23, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.