FDA 510(k)

鈴木AVM微釘應用器

K 號：K221524 · 2022-06-24

決定日期2022-06-24

產品代碼HCI

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

Sugita AVM Microclip Applier is the device name listed in this FDA 510(k) record. The listed applicant is Mizuho America, Inc.. It received FDA 510(k) clearance on 2022-06-24 under 510(k) number K221524. The device is classified under product code HCI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Sugita AVM Microclip Applier?

Sugita AVM Microclip Applier is a medical device that received FDA 510(k) clearance on 2022-06-24. The listed applicant is Mizuho America, Inc.. The 510(k) number is K221524.

When did Sugita AVM Microclip Applier receive FDA 510(k) clearance?

Sugita AVM Microclip Applier received FDA 510(k) clearance on 2022-06-24, under 510(k) number K221524.

Who is the listed applicant for Sugita AVM Microclip Applier?

The FDA 510(k) record lists Mizuho America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sugita AVM Microclip Applier?

The FDA product code for Sugita AVM Microclip Applier is HCI.

其他以 Mizuho America, Inc. 為申請人之記錄

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。

K211183鈴木AVM微釘

相關器械（代碼：HCI）

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。

K211572Aesculap Slim Clip ApplierAesculap, Inc.K180914Aesculap Slim Clip ApplierAesculap, Inc.K173271Aesculap Slim Clip Applier 鐵鎚Aesculap, Inc.

官方來源

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