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FDA 510(k)

DiLumen Endolumenal Interventional Platform

K-Number: K162428 · 2016-12-06

ApplicantLumendi, LLC
Decision Date2016-12-06
Product CodeFDF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DiLumen Endolumenal Interventional Platform is a medical device manufactured by Lumendi, LLC. It received FDA 510(k) clearance on 2016-12-06 under approval number K162428. The device is classified under product code FDF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DiLumen Endolumenal Interventional Platform?

DiLumen Endolumenal Interventional Platform is a medical device that received FDA 510(k) clearance on 2016-12-06. It is manufactured by Lumendi, LLC. The 510(k) number is K162428.

When was DiLumen Endolumenal Interventional Platform approved by the FDA?

DiLumen Endolumenal Interventional Platform received FDA 510(k) clearance on 2016-12-06, under approval number K162428.

What company makes DiLumen Endolumenal Interventional Platform?

DiLumen Endolumenal Interventional Platform is manufactured by Lumendi, LLC.

What is the FDA product code for DiLumen Endolumenal Interventional Platform?

The FDA product code for DiLumen Endolumenal Interventional Platform is FDF.

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Other Devices by Lumendi, LLC

K182540DiLumen Endolumenal Interventional Platform K173405DiLumen Endolumenal Interventional Scissors (DiLumen Is) K173317DiLumen C2; DiLumen Tool Mount K183112DiLumen Endolumenal Interventional Knife (“DiLumen IK™”) K211819DiLumen C2 and Tool Mount K210851DiLumen Endolumenal Interventional Platform (DiLumen)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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