FDA 510(k)

IPGTFL-02

K号: K251100 · 2025-09-19

决定日期2025-09-19

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

IPGTFL-02 is the device name listed in this FDA 510(k) record. The listed applicant is Ipg Medical Corporation. It received FDA 510(k) clearance on 2025-09-19 under 510(k) number K251100. 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 IPGTFL-02?

IPGTFL-02 is a medical device that received FDA 510(k) clearance on 2025-09-19. The listed applicant is Ipg Medical Corporation. The 510(k) number is K251100.

When did IPGTFL-02 receive FDA 510(k) clearance?

IPGTFL-02 received FDA 510(k) clearance on 2025-09-19, under 510(k) number K251100.

Who is the listed applicant for IPGTFL-02?

The FDA 510(k) record lists Ipg Medical Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IPGTFL-02?

The FDA product code for IPGTFL-02 is GEX. This falls under the Gastroenterology category.

列明Ipg Medical Corporation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。

K232568IPG Thulium光纤激光器医疗系列，手术光纤和附件

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。