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Lumendi, LLC

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
8
Inspections
2
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K221452DiLumen C1, EZ1 and Tool MountFebruary 10, 2023
K211819DiLumen C2 and Tool MountOctober 22, 2021
K210851DiLumen Endolumenal Interventional Platform (DiLumen)April 21, 2021
K183112DiLumen Endolumenal Interventional Knife (“DiLumen IK™”)August 2, 2019
K182540DiLumen Endolumenal Interventional PlatformOctober 30, 2018
K173405DiLumen Endolumenal Interventional Scissors (DiLumen Is)May 22, 2018
K173317DiLumen C2; DiLumen Tool MountApril 17, 2018
K162428DiLumen Endolumenal Interventional PlatformDecember 6, 2016