FDA.reportPublic FDA data

PRODEON MEDICAL, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
PRODEON MEDICAL, INC.5N2026-01-012200 Zanker Rd Ste F San Jose CA US 95131

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3498281312999910K253525Urocross Expander System (Model Numbers ES2018 and ES3025)QKA2026-03-12
3498281653438238K252572Prodeon Urethral Sheath SystemFED2025-10-07

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
QKA12026-03-12
FED12025-10-07