FDA 510(k)

Quanta系统外科激光光纤

K号: K160513 · 2016-03-18

决定日期2016-03-18

产品代码GEX

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决定实质等同

器械摘要

Quanta System Surgical Laser fibers is the device name listed in this FDA 510(k) record. The listed applicant is Quanta System Spa. It received FDA 510(k) clearance on 2016-03-18 under 510(k) number K160513. 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 Quanta System Surgical Laser fibers?

Quanta System Surgical Laser fibers is a medical device that received FDA 510(k) clearance on 2016-03-18. The listed applicant is Quanta System Spa. The 510(k) number is K160513.

When did Quanta System Surgical Laser fibers receive FDA 510(k) clearance?

Quanta System Surgical Laser fibers received FDA 510(k) clearance on 2016-03-18, under 510(k) number K160513.

Who is the listed applicant for Quanta System Surgical Laser fibers?

The FDA 510(k) record lists Quanta System Spa as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Quanta System Surgical Laser fibers?

The FDA product code for Quanta System Surgical Laser fibers is GEX. This falls under the Gastroenterology category.

列明Quanta System Spa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。

K240983Discovery Pico; Discovery Pico Plus; Discovery Pico Derm K243588一次性CO2激光光纤 (HAF005001)K241092优激光PRIME；优激光PRIME CO2；优激光PRIME MT K242251Litho 60; Litho 100; Litho 150 K232236Echo K223404Duetto Suprema；Domino Suprema；Suprema VT；Suprema VT+；Suprema 4V

查看所有 34 个设备 →

官方来源

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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。