Medical Device Manufacturer · US , Bellevue , WA

Uroviu Corporation - FDA 510(k) Cleared Devices

7 submissions · 7 cleared · Since 2018

Recent clearances: UV5000W Handle, UV5000 Handle, Uro-G HD Cystoscope (1520)

7

Total

7

Cleared

0

Denied

FDA 510(k) Regulatory Record - Uroviu Corporation Gastroenterology & Urology ✕

7 devices

1-7 of 7

Cleared Oct 23, 2025

Gastroenterology & Urology · 24d

Cleared Sep 11, 2025

Gastroenterology & Urology · 181d

Cleared Dec 13, 2024

Uro-G HD Cystoscope (1520)

Gastroenterology & Urology · 73d

Cleared Jun 07, 2024

Uro-G HD Flexible Cystoscope

Gastroenterology & Urology · 267d

Cleared May 04, 2021

Uro-G Cystoscope

Gastroenterology & Urology · 217d

Cleared Jul 02, 2019

Uro-N Cystoscope

Gastroenterology & Urology · 263d

Cleared Jan 30, 2018

Uro-V Cystoscope

Gastroenterology & Urology · 252d