FDA 510(k)

Quanta System 外科雷射纖維

K 號：K160513 · 2016-03-18

決定日期2016-03-18

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

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.

常見問題

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.

其他以 Quanta System Spa 為申請人之記錄

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相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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