FDA 510(k)

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K番号: K173827 · 2018-09-14

決定日2018-09-14

製品コードGEX

諮問委員会SU

決定Substantially Equivalent

医療機器の概要

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.

よくある質問

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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医療機器の概要

よくある質問

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関連機器（コード：GEX）

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