FDA 510(k)

OmniGuide RFID 外科激光纖維

K 號：K230819 · 2023-04-21

決定日期2023-04-21

產品代碼GEX

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

OmniGuide RFID Surgical Laser 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 2023-04-21 under 510(k) number K230819. 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.

常見問題

What is the OmniGuide RFID Surgical Laser Fibers?

OmniGuide RFID Surgical Laser Fibers is a medical device that received FDA 510(k) clearance on 2023-04-21. The listed applicant is Omni-Guide Holdings, Inc.. The 510(k) number is K230819.

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

OmniGuide RFID Surgical Laser Fibers received FDA 510(k) clearance on 2023-04-21, under 510(k) number K230819.

Who is the listed applicant for OmniGuide RFID Surgical Laser 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 OmniGuide RFID Surgical Laser Fibers?

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

其他以 Omni-Guide Holdings, Inc. 為申請人之記錄

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相關器械（代碼：GEX）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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