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FDA 510(k)

DiLumen Endolumenal Interventional Platform (DiLumen)

K-Number: K210851 · 2021-04-21

ApplicantLumendi, LLC
Decision Date2021-04-21
Product CodeFDF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DiLumen Endolumenal Interventional Platform (DiLumen) is a medical device manufactured by Lumendi, LLC. It received FDA 510(k) clearance on 2021-04-21 under approval number K210851. 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)?

DiLumen Endolumenal Interventional Platform (DiLumen) is a medical device that received FDA 510(k) clearance on 2021-04-21. It is manufactured by Lumendi, LLC. The 510(k) number is K210851.

When was DiLumen Endolumenal Interventional Platform (DiLumen) approved by the FDA?

DiLumen Endolumenal Interventional Platform (DiLumen) received FDA 510(k) clearance on 2021-04-21, under approval number K210851.

What company makes DiLumen Endolumenal Interventional Platform (DiLumen)?

DiLumen Endolumenal Interventional Platform (DiLumen) is manufactured by Lumendi, LLC.

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

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

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Other Devices by Lumendi, LLC

K162428DiLumen Endolumenal Interventional Platform 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

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Related Devices (Code: FDF)

K162428DiLumen Endolumenal Interventional PlatformLumendi, LLC K162622Fujifilm Endoscope Models EC-600HL and EC-600LSFujifilm Medical Systems U.S.A, Inc. K160015Pure VuMotus GI Medical Technologies , Ltd. K161355invendoscopy E200 SystemInvendo Medical GmbH K161791Aer-O-Scope Colonoscope SystemGi View , Ltd. K160356Third Eye Panoramic Auxiliary Endoscopy System - ResposableAvantis Medical Systems, Inc.

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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