Lumendi L L C

FDA Filings

This page includes the latest FDA filings for Lumendi L L C. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3013505983
• FEI Number: 3013505983
• Name: LUMENDI, LLC
• Owner & Operator: Lumendi, LLC
• Contact Address: 253 Post Road W ; Westport CT 06880 US
• Official Correspondent:
  • Dennis J Daniels
  • x-203-5576335-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 253 Post Road W ; Westport, CT 06880 US
• Establishment Type: Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
GUDID 00858836007195 LUMENDI LLC	DiLumen EZ1, 103 cm D-1101	2023-05-09
GUDID 00858836007188 LUMENDI LLC	DiLumen C1, 103 cm D-2101	2023-05-09
GUDID 00858836007171 LUMENDI LLC	DiLumen EZ1, 130 cm D-1100	2023-05-09
GUDID 00858836007164 LUMENDI LLC	DiLumen C1, 130 cm D-2100	2023-05-09
PMN K211819 Lumendi, LLC	DiLumen C2 And Tool Mount	2021-10-22
PMN K210851 Lumendi, LLC	DiLumen Endolumenal Interventional Platform (DiLumen)	2021-04-21
GUDID 00858836007102 LUMENDI LLC	DiLumen Interventional Grasper D-3010	2020-09-02
GUDID 00858836007058 LUMENDI LLC	DiLumen Ik Endolumenal Interventional Knife D-3201	2020-02-06
GUDID 00858836007041 LUMENDI LLC	DiLumen Ik Endolumenal Interventional Knife D-3200	2020-02-06
GUDID 00858836007089 LUMENDI LLC	DiLumen C2 D-2005	2020-01-03
GUDID 00858836007065 LUMENDI LLC	DiLumen C2 D-2004	2020-01-03
PMN K183112 | GEI LUMENDI, LLC	DiLumen Ik, Endolumenal Interventional Kinfe	2019-08-28
GUDID 00865309000287 LUMENDI LLC	DiLumen Ig Interventional Grasper D-3000	2019-08-21
GUDID 00865309000256 LUMENDI LLC	DiLumen Ig Interventional Grasper D-3001	2019-08-21
PMN K183112 Lumendi, LLC	DiLumen Endolumenal Interventional Knife (“DiLumen IK™”)	2019-08-02
GUDID 00858836007003 LUMENDI LLC	DiLumen Im Interventional Tool Mount D-4000	2019-03-11
GUDID 10865309000239 LUMENDI LLC	DiLumen Endolumenal Interventional Platform, 103 cm D-1002	2019-01-21
GUDID 00865309000225 LUMENDI LLC	DiLumen Endolumenal Interventional Platform, 130 cm D-1001	2019-01-21
GUDID 10865309000246 LUMENDI LLC	DiLumen C2 D-2000	2019-01-14
GUDID 10858836007031 LUMENDI LLC	DiLumen C2 D-2002	2019-01-14
GUDID 10858836007024 LUMENDI LLC	DiLumen C2 D-2001	2019-01-14
GUDID 00865309000270 LUMENDI LLC	DiLumen Is Endolumenal Interventional Scissors D-3100	2019-01-14
GUDID 00865309000263 LUMENDI LLC	DiLumen Is Endolumenal Interventional Scissors D-3101	2019-01-14
PMN K182540 | FDF LUMENDI, LLC	DiLumen Endolumenal Intervventional Platform	2018-12-14
PMN K182540 Lumendi, LLC	DiLumen Endolumenal Interventional Platform	2018-10-30
PTS LUMENDI, LLC	DiLumen Ig, Endolumenal Interventional Grasper	2018-10-03
GUDID 00865309000201 LUMENDI LLC	DiLumen Endolumenal Interventional Platform D-1000	2018-07-06
PMN K173405 | GEI LUMENDI, LLC	DiLumen Is	2018-05-23
PMN K173317 | FDF LUMENDI, LLC	DiLumen C2	2018-05-23
PMN K173405 Lumendi, LLC	DiLumen Endolumenal Interventional Scissors (DiLumen Is)	2018-05-22
PMN K173317 Lumendi, LLC	DiLumen C2; DiLumen Tool Mount	2018-04-17
PMN K162428 | FDF LUMENDI, LLC	DiLumen Endolumenal Interventional Platform	2017-03-05
PMN K162428 Lumendi, LLC	DiLumen Endolumenal Interventional Platform	2016-12-06