FDA 510(k)

一次性无菌医用激光光纤

K号: K202601 · 2020-12-15

申请人Realton (Suzhou) Medical Technology Co., Ltd.

决定日期2020-12-15

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

Single-use Sterile medical 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 2020-12-15 under 510(k) number K202601. 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 Single-use Sterile medical laser fiber?

Single-use Sterile medical laser fiber is a medical device that received FDA 510(k) clearance on 2020-12-15. The listed applicant is Realton (Suzhou) Medical Technology Co., Ltd.. The 510(k) number is K202601.

When did Single-use Sterile medical laser fiber receive FDA 510(k) clearance?

Single-use Sterile medical laser fiber received FDA 510(k) clearance on 2020-12-15, under 510(k) number K202601.

Who is the listed applicant for Single-use Sterile medical 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 Single-use Sterile medical laser fiber?

The FDA product code for Single-use Sterile medical laser fiber is GEX. This falls under the Gastroenterology category.

列明Realton (Suzhou) Medical Technology Co., Ltd.为申报人的其他记录

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