FDA.reportPublic FDA data

UVISION360, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30148346233014834623UVISION360, INC.1N2020-04-25158 Wind Chime Court Suite #201 Raleigh NC US 27615

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2230871714410507K192278Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable Sheath (Diagnostic)HIH2019-11-01
2230871250802390K190827Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath RigidHIH2019-06-06
2230871299314212K181909Luminelle DTx Hysteroscopy SystemFAJ2018-08-16

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HIH22019-11-01
FAJ12018-08-16

PMN#