FDA.reportPublic FDA data

LUMENDI, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30135059833013505983LUMENDI, LLC1N2026-01-01253 Post Road W Westport CT US 06880

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2054761918866193K221452DiLumen C1, EZ1 and Tool MountFDF2023-02-10
2054761959725385K211819DiLumen C2 and Tool MountFDF2021-10-22
2054761421436683K210851DiLumen Endolumenal Interventional Platform (DiLumen)FDF2021-04-21
2054762056410337K183112DiLumen Endolumenal Interventional Knife (“DiLumen IK™”)GEI2019-08-02
2054762067190449K182540DiLumen Endolumenal Interventional PlatformFDF2018-10-30
2054761231816629K173405DiLumen Endolumenal Interventional Scissors (DiLumen Is)GEI2018-05-22
2054761590041773K173317DiLumen C2; DiLumen Tool MountFDF2018-04-17
2054761738174925K162428DiLumen Endolumenal Interventional PlatformFDF2016-12-06
2054762036230196

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FDF62023-02-10
GEI22019-08-02

PMN#