FDA 510(k)

LISA激光手术光纤

K号: K220189 · 2022-04-29

决定日期2022-04-29

产品代码GEX

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决定实质等同

器械摘要

LISA Laser Surgical Fibers is the device name listed in this FDA 510(k) record. The listed applicant is Omni-Guide Holdings, Inc.. It received FDA 510(k) clearance on 2022-04-29 under 510(k) number K220189. 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 LISA Laser Surgical Fibers?

LISA Laser Surgical Fibers is a medical device that received FDA 510(k) clearance on 2022-04-29. The listed applicant is Omni-Guide Holdings, Inc.. The 510(k) number is K220189.

When did LISA Laser Surgical Fibers receive FDA 510(k) clearance?

LISA Laser Surgical Fibers received FDA 510(k) clearance on 2022-04-29, under 510(k) number K220189.

Who is the listed applicant for LISA Laser Surgical Fibers?

The FDA 510(k) record lists Omni-Guide Holdings, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LISA Laser Surgical Fibers?

The FDA product code for LISA Laser Surgical Fibers is GEX. This falls under the Gastroenterology category.

列明Omni-Guide Holdings, Inc.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。

K230819OmniGuide RFID 外科激光光纤

官方来源

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