Lumendi, LLC is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Lumendi, LLC - FDA 510(k) Cleared Devices
Recent clearances: DiLumen C1, EZ1 and Tool Mount, DiLumen C2 and Tool Mount, DiLumen Endolumenal Interventional Platform (DiLumen)
8
Total
8
Cleared
0
Denied
Lumendi, LLC has 8 FDA 510(k) cleared medical devices. Based in Westport, US.
Last cleared in 2023. Active since 2016. Primary specialty: Gastroenterology & Urology.
Browse the FDA 510(k) cleared devices submitted by Lumendi, LLC Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Hogan Lovells US LLP as regulatory consultant.
FDA 510(k) Regulatory Record - Lumendi, LLC
8 devices
Cleared
Feb 10, 2023
DiLumen C1, EZ1 and Tool Mount
Gastroenterology & Urology
268d
Cleared
Oct 22, 2021
DiLumen C2 and Tool Mount
Gastroenterology & Urology
133d
Cleared
Apr 21, 2021
DiLumen Endolumenal Interventional Platform (DiLumen)
Gastroenterology & Urology
30d
Cleared
Aug 02, 2019
DiLumen Endolumenal Interventional Knife (“DiLumen IK™”)
Gastroenterology & Urology
267d
Cleared
Oct 30, 2018
DiLumen Endolumenal Interventional Platform
Gastroenterology & Urology
46d
Cleared
May 22, 2018
DiLumen Endolumenal Interventional Scissors (DiLumen Is)
General & Plastic Surgery
203d
Cleared
Apr 17, 2018
DiLumen C2
Gastroenterology & Urology
180d
Cleared
Dec 06, 2016
DiLumen Endolumenal Interventional Platform
Gastroenterology & Urology
98d