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FDA 510(k)

DiLumen Endolumenal Interventional Scissors (DiLumen Is)

K-Number: K173405 · 2018-05-22

ApplicantLumendi, LLC
Decision Date2018-05-22
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DiLumen Endolumenal Interventional Scissors (DiLumen Is) is a medical device manufactured by Lumendi, LLC. It received FDA 510(k) clearance on 2018-05-22 under approval number K173405. 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 Scissors (DiLumen Is)?

DiLumen Endolumenal Interventional Scissors (DiLumen Is) is a medical device that received FDA 510(k) clearance on 2018-05-22. It is manufactured by Lumendi, LLC. The 510(k) number is K173405.

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

DiLumen Endolumenal Interventional Scissors (DiLumen Is) received FDA 510(k) clearance on 2018-05-22, under approval number K173405.

What company makes DiLumen Endolumenal Interventional Scissors (DiLumen Is)?

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

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

The FDA product code for DiLumen Endolumenal Interventional Scissors (DiLumen Is) 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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