FDA 510(k)

超聲手術系統

K 號：K233036 · 2024-06-18

申請人Hunan Handlike Minimally Invasive Surgery Co., Ltd.

決定日期2024-06-18

產品代碼LFL

決定相當於

器材摘要

Ultrasonic Surgical System is the device name listed in this FDA 510(k) record. The listed applicant is Hunan Handlike Minimally Invasive Surgery Co., Ltd.. It received FDA 510(k) clearance on 2024-06-18 under 510(k) number K233036. The device is classified under product code LFL. FDA Decision: Substantially Equivalent.

常見問題

What is the Ultrasonic Surgical System?

Ultrasonic Surgical System is a medical device that received FDA 510(k) clearance on 2024-06-18. The listed applicant is Hunan Handlike Minimally Invasive Surgery Co., Ltd.. The 510(k) number is K233036.

When did Ultrasonic Surgical System receive FDA 510(k) clearance?

Ultrasonic Surgical System received FDA 510(k) clearance on 2024-06-18, under 510(k) number K233036.

Who is the listed applicant for Ultrasonic Surgical System?

The FDA 510(k) record lists Hunan Handlike Minimally Invasive Surgery Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ultrasonic Surgical System?

The FDA product code for Ultrasonic Surgical System is LFL.

其他以 Hunan Handlike Minimally Invasive Surgery Co., Ltd. 為申請人之記錄

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K171825一次性內視鏡手術器械，可重複使用內視鏡手術器械

相關器械（代碼：LFL）

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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