FDA.reportPublic FDA data

UROTRONIC INC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30152288753015228875UROTRONIC INC1N2026-01-012495 Xenium Lane North Plymouth MN US 55441

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2403031008523065P220029Optilume™ BPH Catheter SystemQXB2023-06-30
2403032073184045P210020Optilume Urethral Drug Coated BalloonQRH2021-12-03
2403031345776492K191061Optilume Basic Urological Balloon Dilation CatheterKOE2020-01-02

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
QRH 12021-12-03
KOE12020-01-02

PMN#