FDA.reportPublic FDA data

UROVIU CORPORATION

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30150422093015042209UROVIU CORPORATION1N2026-01-014546 El Camino Real Suite 214 Los Altos CA US 94022

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2227081884715819K253226UV5000W HandleFAJ2025-10-23
2227081739462515K250797UV5000 HandleFAJ2025-09-11
2227081057068142K232837Uro-G HD Flexible CystoscopeFAJ2024-06-07
2227082066500138K202921Uro-G CystoscopeFAJ2021-05-04
2227081544998389K202445Hystero-V HysteroscopeHIH2021-11-23
2227081025073528K182876Uro-N CystoscopeFAJ2019-07-02
2227081049458926K171500Uro-V CystoscopeFAJ2018-01-30
2227081114287020
2227081424320998

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FAJ72025-10-23
HIH12021-11-23

PMN#