Uroviu Corporation FDA Approvals

0 new drug approvals and 5 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
UV5000W Handle510(k)Oct 23, 2025Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Special)	Oct 23, 2025
UV5000 Handle510(k)Sep 11, 2025Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Sep 11, 2025
Uro-G HD Cystoscope (1520)510(k)Dec 13, 2024Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Special)	Dec 13, 2024
Uro-G HD Flexible Cystoscope510(k)Jun 7, 2024Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Jun 7, 2024
Uro-G Cystoscope510(k)May 4, 2021Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	May 4, 2021