FDA 510(k)

Pastelle Pro

K号: K241527 · 2025-02-14

决定日期2025-02-14

产品代码GEX

咨询委员会SU

决定Substantially Equivalent

器械摘要

Pastelle Pro is the device name listed in this FDA 510(k) record. The listed applicant is Wontech Co., Ltd.. It received FDA 510(k) clearance on 2025-02-14 under 510(k) number K241527. 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 Pastelle Pro?

Pastelle Pro is a medical device that received FDA 510(k) clearance on 2025-02-14. The listed applicant is Wontech Co., Ltd.. The 510(k) number is K241527.

When did Pastelle Pro receive FDA 510(k) clearance?

Pastelle Pro received FDA 510(k) clearance on 2025-02-14, under 510(k) number K241527.

Who is the listed applicant for Pastelle Pro?

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

What is the FDA product code for Pastelle Pro?

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

列明Wontech Co., Ltd.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。

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