FDA 510(k)

LightScalpel

Número K: K173827 · 2018-09-14

Data da decisão2018-09-14

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

LightScalpel is the device name listed in this FDA 510(k) record. The listed applicant is Lightscalpel, LLC. It received FDA 510(k) clearance on 2018-09-14 under 510(k) number K173827. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the LightScalpel?

LightScalpel is a medical device that received FDA 510(k) clearance on 2018-09-14. The listed applicant is Lightscalpel, LLC. The 510(k) number is K173827.

When did LightScalpel receive FDA 510(k) clearance?

LightScalpel received FDA 510(k) clearance on 2018-09-14, under 510(k) number K173827.

Who is the listed applicant for LightScalpel?

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

What is the FDA product code for LightScalpel?

The FDA product code for LightScalpel is GEX. This falls under the Gastroenterology category.

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