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FDA 510(k)

Arthrex Beaming系統

K 號:K262975 · 2026-09-25

申請人Arthrex, Inc.
決定日期2026-09-25
產品代碼HWC
諮詢委員會OR
決定Substantially Equivalent

器材摘要

Arthrex Beaming System is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2026-09-25 under 510(k) number K262975. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常見問題

What is the Arthrex Beaming System?

Arthrex Beaming System is a medical device that received FDA 510(k) clearance on 2026-09-25. The listed applicant is Arthrex, Inc.. The 510(k) number is K262975.

When did Arthrex Beaming System receive FDA 510(k) clearance?

Arthrex Beaming System received FDA 510(k) clearance on 2026-09-25, under 510(k) number K262975.

Who is the listed applicant for Arthrex Beaming System?

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

What is the FDA product code for Arthrex Beaming System?

The FDA product code for Arthrex Beaming System is HWC. This falls under the Cardiovascular category.

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其他以 Arthrex, Inc. 為申請人之記錄

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相關器械(代碼:HWC)

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官方來源

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