ELUCENT MEDICAL INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30146531993014653199ELUCENT MEDICAL INC.1N2026-01-016509 Flying Cloud Drive Suite 160 Eden Prairie MN US 55344

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2200061285477840K233639SmartClip Secure Soft Tissue MarkerNEU2024-12-20
2200061118849787K183400EnVisio Navigation SytemNEU2019-03-22
2200061874752718K180640SmartClip Soft Tissue MarkerNEU2018-06-04
2200061508841592

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NEU32024-12-20