FDA 510(k)

DiLumen Endolumenal Interventional Knife (“DiLumen IK™”)

Número K: K183112 · 2019-08-02

Data da decisão2019-08-02

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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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)K182540DiLumen Endolumenal Interventional Platform K173405DiLumen Endolumenal Interventional Scissors (DiLumen Is)K173317DiLumen C2; DiLumen Tool Mount

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Fonte oficial

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