FDA 510(k)

Hemospray內視鏡止血器（HEMO-[X])

K 號：K253302 · 2026-06-02

決定日期2026-06-02

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 (HEMO-[X]) 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 2026-06-02 under 510(k) number K253302. 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 (HEMO-[X])?

Hemospray Endoscopic Hemostat (HEMO-[X]) is a medical device that received FDA 510(k) clearance on 2026-06-02. The listed applicant is Wilson-Cook Medical, Inc.. The 510(k) number is K253302.

When did Hemospray Endoscopic Hemostat (HEMO-[X]) receive FDA 510(k) clearance?

Hemospray Endoscopic Hemostat (HEMO-[X]) received FDA 510(k) clearance on 2026-06-02, under 510(k) number K253302.

Who is the listed applicant for Hemospray Endoscopic Hemostat (HEMO-[X])?

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 (HEMO-[X])?

The FDA product code for Hemospray Endoscopic Hemostat (HEMO-[X]) 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。

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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。

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官方來源

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