FDA 510(k)

Hemospray 内镜止血夹 (HEMO-[X])

K号: K253302 · 2026-06-02

决定日期2026-06-02

产品代码QAU

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决定实质等同

器械摘要

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.

常见问题

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.

列明Wilson-Cook Medical, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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官方来源

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