FDA 510(k)

HandPICO

K号: K220041 · 2022-05-05

申请人Vydence Medical Industria E Comercio Ltda

决定日期2022-05-05

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

HandPICO is the device name listed in this FDA 510(k) record. The listed applicant is Vydence Medical Industria E Comercio Ltda. It received FDA 510(k) clearance on 2022-05-05 under 510(k) number K220041. 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 HandPICO?

HandPICO is a medical device that received FDA 510(k) clearance on 2022-05-05. The listed applicant is Vydence Medical Industria E Comercio Ltda. The 510(k) number is K220041.

When did HandPICO receive FDA 510(k) clearance?

HandPICO received FDA 510(k) clearance on 2022-05-05, under 510(k) number K220041.

Who is the listed applicant for HandPICO?

The FDA 510(k) record lists Vydence Medical Industria E Comercio Ltda as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HandPICO?

The FDA product code for HandPICO is GEX. This falls under the Gastroenterology category.

列明Vydence Medical Industria E Comercio Ltda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。

K202998Vydence Zye 和 Vydence One K190007Vydence激光系列 K171443Etherea MX

官方来源

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