FDA 510(k)

A.R.C. 激光手术光纤和探头

K号: K161403 · 2016-08-16

决定日期2016-08-16

产品代码GEX

咨询委员会SU 请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。

决定实质等同

器械摘要

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.

常见问题

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.

列明A.R.C Laser GmbH为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K220531FOX 810, FOX 980 K192272狼445nm K170183Cetus系统，Cetus探头

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。