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FDA 510(k)

121型組織切片針，111型組織切片針，112型組織切片針，以及131型一次性同軸組織切片針

K 號：K214063 · 2022-06-03

申請人Guangzhou Shengwei Medical Devices Co., Ltd.
決定日期2022-06-03
產品代碼KNW
諮詢委員會GU
決定相當於

器材摘要

Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131 Disposable Coaxial Biopsy Needle is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Shengwei Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2022-06-03 under 510(k) number K214063. 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 Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131 Disposable Coaxial Biopsy Needle?

Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131 Disposable Coaxial Biopsy Needle is a medical device that received FDA 510(k) clearance on 2022-06-03. The listed applicant is Guangzhou Shengwei Medical Devices Co., Ltd.. The 510(k) number is K214063.

When did Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131 Disposable Coaxial Biopsy Needle receive FDA 510(k) clearance?

Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131 Disposable Coaxial Biopsy Needle received FDA 510(k) clearance on 2022-06-03, under 510(k) number K214063.

Who is the listed applicant for Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131 Disposable Coaxial Biopsy Needle?

The FDA 510(k) record lists Guangzhou Shengwei Medical Devices Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131 Disposable Coaxial Biopsy Needle?

The FDA product code for Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131 Disposable Coaxial Biopsy Needle is KNW.

相關臨床試驗

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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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