FDA 510(k)

PuraStat-GI

K 號：K210098 · 2021-06-25

決定日期2021-06-25

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-GI 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 2021-06-25 under 510(k) number K210098. 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-GI?

PuraStat-GI is a medical device that received FDA 510(k) clearance on 2021-06-25. The listed applicant is 3-D Matrix, Inc.. The 510(k) number is K210098.

When did PuraStat-GI receive FDA 510(k) clearance?

PuraStat-GI received FDA 510(k) clearance on 2021-06-25, under 510(k) number K210098.

Who is the listed applicant for PuraStat-GI?

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-GI?

The FDA product code for PuraStat-GI 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 K222481PuraStat K213552PuraStat-RM K210211PuraStat-OM K193085PuraDERM膠

查看所有 8 項裝置 →

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

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。