FDA 510(k)

FLARE Single-Use Surgical Laser Fiber

Número K: K202702 · 2021-02-26

RequerenteRealton (Suzhou) Medical Technology Co., Ltd.

Data da decisão2021-02-26

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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