FDA 510(k)

U-Blade 腹腔針

K 號：K162648 · 2016-12-12

申請人Tianjin Uwell Medical Device Manufacturing Co., Ltd.

決定日期2016-12-12

產品代碼HIF

諮詢委員會OB設備之醫療設備規範文本翻譯如下：關於OB設備的醫療設備規範文件：此設備已通過FDA認證，並獲得510(k)許可證。該設備的PMA申請已提交，並在NCT登錄編號為[編號]的研究中進行測試。相關文獻的PMID編號為[編號]。請參考以下識別碼和網址：識別碼：[識別碼] 網址：[網址] 政策：醫療規範-v1

決定相當於

器材摘要

U-Blade Veress Needle is the device name listed in this FDA 510(k) record. The listed applicant is Tianjin Uwell Medical Device Manufacturing Co., Ltd.. It received FDA 510(k) clearance on 2016-12-12 under 510(k) number K162648. The device is classified under product code HIF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the U-Blade Veress Needle?

U-Blade Veress Needle is a medical device that received FDA 510(k) clearance on 2016-12-12. The listed applicant is Tianjin Uwell Medical Device Manufacturing Co., Ltd.. The 510(k) number is K162648.

When did U-Blade Veress Needle receive FDA 510(k) clearance?

U-Blade Veress Needle received FDA 510(k) clearance on 2016-12-12, under 510(k) number K162648.

Who is the listed applicant for U-Blade Veress Needle?

The FDA 510(k) record lists Tianjin Uwell Medical Device Manufacturing Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for U-Blade Veress Needle?

The FDA product code for U-Blade Veress Needle is HIF.

其他以 Tianjin Uwell Medical Device Manufacturing Co., Ltd. 為申請人之記錄

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