FDA 510(k)

A.R.C. 激光外科纖維和探針

K 號：K161403 · 2016-08-16

決定日期2016-08-16

產品代碼GEX

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

A.R.C. Laser Surgical Fibers and Probes is the device name listed in this FDA 510(k) record. The listed applicant is A.R.C Laser GmbH. It received FDA 510(k) clearance on 2016-08-16 under 510(k) number K161403. 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.

常見問題

What is the A.R.C. Laser Surgical Fibers and Probes?

A.R.C. Laser Surgical Fibers and Probes is a medical device that received FDA 510(k) clearance on 2016-08-16. The listed applicant is A.R.C Laser GmbH. The 510(k) number is K161403.

When did A.R.C. Laser Surgical Fibers and Probes receive FDA 510(k) clearance?

A.R.C. Laser Surgical Fibers and Probes received FDA 510(k) clearance on 2016-08-16, under 510(k) number K161403.

Who is the listed applicant for A.R.C. Laser Surgical Fibers and Probes?

The FDA 510(k) record lists A.R.C Laser GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for A.R.C. Laser Surgical Fibers and Probes?

The FDA product code for A.R.C. Laser Surgical Fibers and Probes is GEX. This falls under the Gastroenterology category.

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