FDA 510(k)

DiLumen Endolumenal Interventional Scissors (DiLumen Is)

Número K: K173405 · 2018-05-22

Data da decisão2018-05-22

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

DiLumen Endolumenal Interventional Scissors (DiLumen Is) is the device name listed in this FDA 510(k) record. The listed applicant is Lumendi, LLC. It received FDA 510(k) clearance on 2018-05-22 under 510(k) number K173405. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

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. The listed applicant is Lumendi, LLC. The 510(k) number is K173405.

When did DiLumen Endolumenal Interventional Scissors (DiLumen Is) receive FDA 510(k) clearance?

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

Who is the listed applicant for DiLumen Endolumenal Interventional Scissors (DiLumen Is)?

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 Scissors (DiLumen Is)?

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

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Outros registros que listam Lumendi, LLC como candidato(a)

K221452DiLumen C1, EZ1 and Tool Mount K211819DiLumen C2 and Tool Mount K210851DiLumen Endolumenal Interventional Platform (DiLumen)K183112DiLumen Endolumenal Interventional Knife (“DiLumen IK™”)K182540DiLumen Endolumenal Interventional Platform K173317DiLumen C2; DiLumen Tool Mount

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Fonte oficial

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