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FDA 510(k)

DiLumen Endolumenal Interventional Knife (“DiLumen IK™”)

K-Number: K183112 · 2019-08-02

ApplicantLumendi, LLC
Decision Date2019-08-02
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DiLumen Endolumenal Interventional Knife (“DiLumen IK™”) is a medical device manufactured by Lumendi, LLC. It received FDA 510(k) clearance on 2019-08-02 under approval number K183112. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DiLumen Endolumenal Interventional Knife (“DiLumen IK™”)?

DiLumen Endolumenal Interventional Knife (“DiLumen IK™”) is a medical device that received FDA 510(k) clearance on 2019-08-02. It is manufactured by Lumendi, LLC. The 510(k) number is K183112.

When was DiLumen Endolumenal Interventional Knife (“DiLumen IK™”) approved by the FDA?

DiLumen Endolumenal Interventional Knife (“DiLumen IK™”) received FDA 510(k) clearance on 2019-08-02, under approval number K183112.

What company makes DiLumen Endolumenal Interventional Knife (“DiLumen IK™”)?

DiLumen Endolumenal Interventional Knife (“DiLumen IK™”) is manufactured by Lumendi, LLC.

What is the FDA product code for DiLumen Endolumenal Interventional Knife (“DiLumen IK™”)?

The FDA product code for DiLumen Endolumenal Interventional Knife (“DiLumen IK™”) is GEI.

Other Devices by Lumendi, LLC

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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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