Medical Device Manufacturer · US , Westport , CT

Lumendi, LLC - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 2016

Recent clearances: DiLumen C1, EZ1 and Tool Mount, DiLumen C2 and Tool Mount, DiLumen Endolumenal Interventional Platform (DiLumen)

8
Total
8
Cleared
0
Denied

FDA 510(k) Regulatory Record - Lumendi, LLC Gastroenterology & Urology ✕

7 devices
1-7 of 7
Cleared Feb 10, 2023
DiLumen C1, EZ1 and Tool Mount
K221452 · FDF
Gastroenterology & Urology · 268d
Cleared Oct 22, 2021
DiLumen C2 and Tool Mount
K211819 · FDF
Gastroenterology & Urology · 133d
Cleared Apr 21, 2021
DiLumen Endolumenal Interventional Platform (DiLumen)
K210851 · FDF
Gastroenterology & Urology · 30d
Cleared Aug 02, 2019
DiLumen Endolumenal Interventional Knife (“DiLumen IK™”)
K183112 · GEI
Gastroenterology & Urology · 267d
Cleared Oct 30, 2018
DiLumen Endolumenal Interventional Platform
K182540 · FDF
Gastroenterology & Urology · 46d
Cleared Apr 17, 2018
DiLumen C2
K173317 · FDF
Gastroenterology & Urology · 180d
Cleared Dec 06, 2016
DiLumen Endolumenal Interventional Platform
K162428 · FDF
Gastroenterology & Urology · 98d
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All8 Gastroenterology & Urology 7 General & Plastic Surgery 1