Lumendi, LLC FDA Approvals

0 new drug approvals and 3 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
DiLumen C1, EZ1 and Tool Mount510(k)Feb 10, 2023Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Feb 10, 2023
DiLumen C2 and Tool Mount510(k)Oct 22, 2021Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Oct 22, 2021
DiLumen Endolumenal Interventional Platform (DiLumen)510(k)Apr 21, 2021Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Special)	Apr 21, 2021