FDA 510(k)

VERSAJET 水刀系統 (III)

K 號：K220964 · 2023-05-16

決定日期2023-05-16

產品代碼FQH

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

VERSAJET Hydrosurgery System (III) is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Medical Limited. It received FDA 510(k) clearance on 2023-05-16 under 510(k) number K220964. The device is classified under product code FQH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the VERSAJET Hydrosurgery System (III)?

VERSAJET Hydrosurgery System (III) is a medical device that received FDA 510(k) clearance on 2023-05-16. The listed applicant is Smith & Nephew Medical Limited. The 510(k) number is K220964.

When did VERSAJET Hydrosurgery System (III) receive FDA 510(k) clearance?

VERSAJET Hydrosurgery System (III) received FDA 510(k) clearance on 2023-05-16, under 510(k) number K220964.

Who is the listed applicant for VERSAJET Hydrosurgery System (III)?

The FDA 510(k) record lists Smith & Nephew Medical Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VERSAJET Hydrosurgery System (III)?

The FDA product code for VERSAJET Hydrosurgery System (III) is FQH.

其他以 Smith & Nephew Medical Limited 為申請人之記錄

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相關器械（代碼：FQH）

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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