FDA 510(k)

Restrata®迷你矩陣

K 號：K223725 · 2023-05-18

決定日期2023-05-18

產品代碼QSZ

決定相當於

器材摘要

Restrata® MiniMatrix is the device name listed in this FDA 510(k) record. The listed applicant is Acera Surgical, Inc.. It received FDA 510(k) clearance on 2023-05-18 under 510(k) number K223725. The device is classified under product code QSZ. FDA Decision: Substantially Equivalent.

常見問題

What is the Restrata® MiniMatrix?

Restrata® MiniMatrix is a medical device that received FDA 510(k) clearance on 2023-05-18. The listed applicant is Acera Surgical, Inc.. The 510(k) number is K223725.

When did Restrata® MiniMatrix receive FDA 510(k) clearance?

Restrata® MiniMatrix received FDA 510(k) clearance on 2023-05-18, under 510(k) number K223725.

Who is the listed applicant for Restrata® MiniMatrix?

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

What is the FDA product code for Restrata® MiniMatrix?

The FDA product code for Restrata® MiniMatrix is QSZ.

其他以 Acera Surgical, Inc. 為申請人之記錄

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相關器械（代碼：QSZ）

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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