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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 the device name listed in this FDA 510(k) record. The listed applicant is Lumendi, LLC. It received FDA 510(k) clearance on 2019-08-02 under 510(k) 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. The listed applicant is Lumendi, LLC. The 510(k) number is K183112.

When did DiLumen Endolumenal Interventional Knife (“DiLumen IK™”) receive FDA 510(k) clearance?

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

Who is the listed applicant for DiLumen Endolumenal Interventional Knife (“DiLumen IK™”)?

The FDA 510(k) record lists Lumendi, LLC as the applicant. This does not by itself establish the device manufacturer.

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 records listing Lumendi, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K221452DiLumen C1, EZ1 and Tool MountK211819DiLumen C2 and Tool MountK210851DiLumen Endolumenal Interventional Platform (DiLumen)K182540DiLumen Endolumenal Interventional PlatformK173405DiLumen Endolumenal Interventional Scissors (DiLumen Is)K173317DiLumen C2; DiLumen Tool Mount

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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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