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FDA 510(k)

福斯瓦爾前列腺針吸系統（福斯瓦爾針吸槍和福斯瓦爾針吸針）

K 號：K242128 · 2025-02-27

申請人Xaga Surgical
決定日期2025-02-27
產品代碼KNW
諮詢委員會GU
決定相當於

器材摘要

Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall biopsy needle) is the device name listed in this FDA 510(k) record. The listed applicant is Xaga Surgical. It received FDA 510(k) clearance on 2025-02-27 under 510(k) number K242128. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall biopsy needle)?

Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall biopsy needle) is a medical device that received FDA 510(k) clearance on 2025-02-27. The listed applicant is Xaga Surgical. The 510(k) number is K242128.

When did Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall biopsy needle) receive FDA 510(k) clearance?

Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall biopsy needle) received FDA 510(k) clearance on 2025-02-27, under 510(k) number K242128.

Who is the listed applicant for Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall biopsy needle)?

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

What is the FDA product code for Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall biopsy needle)?

The FDA product code for Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall biopsy needle) is KNW.

相關臨床試驗

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：KNW）

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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