FDA 510(k)

FLARE單次使用外科激光纖維

K 號：K202702 · 2021-02-26

申請人Realton (Suzhou) Medical Technology Co., Ltd.

決定日期2021-02-26

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

FLARE Single-Use Surgical Laser Fiber is the device name listed in this FDA 510(k) record. The listed applicant is Realton (Suzhou) Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-02-26 under 510(k) number K202702. 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 FLARE Single-Use Surgical Laser Fiber?

FLARE Single-Use Surgical Laser Fiber is a medical device that received FDA 510(k) clearance on 2021-02-26. The listed applicant is Realton (Suzhou) Medical Technology Co., Ltd.. The 510(k) number is K202702.

When did FLARE Single-Use Surgical Laser Fiber receive FDA 510(k) clearance?

FLARE Single-Use Surgical Laser Fiber received FDA 510(k) clearance on 2021-02-26, under 510(k) number K202702.

Who is the listed applicant for FLARE Single-Use Surgical Laser Fiber?

The FDA 510(k) record lists Realton (Suzhou) Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FLARE Single-Use Surgical Laser Fiber?

The FDA product code for FLARE Single-Use Surgical Laser Fiber is GEX. This falls under the Gastroenterology category.

其他以 Realton (Suzhou) Medical Technology Co., Ltd. 為申請人之記錄

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