FDA 510(k)

瓜迪尼亞（GAR-1）

K 號：K232701 · 2023-09-29

決定日期2023-09-29

產品代碼GCJ

諮詢委員會GU

決定相當於

器材摘要

Guardenia (GAR-1) is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Surgical Concepts. It received FDA 510(k) clearance on 2023-09-29 under 510(k) number K232701. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Guardenia (GAR-1)?

Guardenia (GAR-1) is a medical device that received FDA 510(k) clearance on 2023-09-29. The listed applicant is Advanced Surgical Concepts. The 510(k) number is K232701.

When did Guardenia (GAR-1) receive FDA 510(k) clearance?

Guardenia (GAR-1) received FDA 510(k) clearance on 2023-09-29, under 510(k) number K232701.

Who is the listed applicant for Guardenia (GAR-1)?

The FDA 510(k) record lists Advanced Surgical Concepts as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Guardenia (GAR-1)?

The FDA product code for Guardenia (GAR-1) is GCJ.

其他以 Advanced Surgical Concepts 為申請人之記錄

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K192898氣管內置管

相關器械（代碼：GCJ）

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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