FDA 510(k)

Hemospray內視鏡止血器

K 號：K200972 · 2020-06-10

決定日期2020-06-10

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

Hemospray Endoscopic Hemostat is the device name listed in this FDA 510(k) record. The listed applicant is Wilson-Cook Medical, Inc.. It received FDA 510(k) clearance on 2020-06-10 under 510(k) number K200972. 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 Hemospray Endoscopic Hemostat?

Hemospray Endoscopic Hemostat is a medical device that received FDA 510(k) clearance on 2020-06-10. The listed applicant is Wilson-Cook Medical, Inc.. The 510(k) number is K200972.

When did Hemospray Endoscopic Hemostat receive FDA 510(k) clearance?

Hemospray Endoscopic Hemostat received FDA 510(k) clearance on 2020-06-10, under 510(k) number K200972.

Who is the listed applicant for Hemospray Endoscopic Hemostat?

The FDA 510(k) record lists Wilson-Cook Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hemospray Endoscopic Hemostat?

The FDA product code for Hemospray Endoscopic Hemostat is QAU.

其他以 Wilson-Cook Medical, 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。

K253302Hemospray內視鏡止血器（HEMO-[X])K243568Tesla雙極肛門切開器；Tesla BiCord活動繩 K213356Entuit PEG，Entuit PEGJ K212323Instinct Plus內視鏡夾合器 K201322恩圖伊特鼻腸管輸食管 K200247融合四合一抽吸球

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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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