FDA 510(k)

PuraStat

K 號：K222481 · 2023-02-28

決定日期2023-02-28

產品代碼QAU

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

PuraStat is the device name listed in this FDA 510(k) record. The listed applicant is 3-D Matrix, Inc.. It received FDA 510(k) clearance on 2023-02-28 under 510(k) number K222481. The device is classified under product code QAU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PuraStat?

PuraStat is a medical device that received FDA 510(k) clearance on 2023-02-28. The listed applicant is 3-D Matrix, Inc.. The 510(k) number is K222481.

When did PuraStat receive FDA 510(k) clearance?

PuraStat received FDA 510(k) clearance on 2023-02-28, under 510(k) number K222481.

Who is the listed applicant for PuraStat?

FDA 510(k) 記錄將 3-D Matrix, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for PuraStat?

The FDA product code for PuraStat is QAU.

其他以 3-D Matrix, 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。

K261503PuraStat 胃腸設備 K261504PuraStat-RM K213552PuraStat-RM K210211PuraStat-OM K210098PuraStat-GI K193085PuraDERM膠

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相關器械（代碼：QAU）

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。

K261503PuraStat 胃腸設備3-D Matrix, Inc.K253302Hemospray內視鏡止血器（HEMO-[X])Wilson-Cook Medical, Inc.K253924PuraStat3-D Matrix Europe SAS K240994NexpowderNextbiomedical Co., Ltd.K242250PuraStat3-D Matrix Europe SAS K234131解決內視鏡止血系統Hemostasis, LLC

官方來源

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