FDA 510(k)

視頻內視鏡系統，3D視頻內視鏡系統

K 號：K210116 · 2021-10-13

申請人Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.

決定日期2021-10-13

產品代碼HET

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

Video Endoscopy System, 3D Video Endoscopy System is the device name listed in this FDA 510(k) record. The listed applicant is Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.. It received FDA 510(k) clearance on 2021-10-13 under 510(k) number K210116. The device is classified under product code HET. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Video Endoscopy System, 3D Video Endoscopy System?

Video Endoscopy System, 3D Video Endoscopy System is a medical device that received FDA 510(k) clearance on 2021-10-13. The listed applicant is Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.. The 510(k) number is K210116.

When did Video Endoscopy System, 3D Video Endoscopy System receive FDA 510(k) clearance?

Video Endoscopy System, 3D Video Endoscopy System received FDA 510(k) clearance on 2021-10-13, under 510(k) number K210116.

Who is the listed applicant for Video Endoscopy System, 3D Video Endoscopy System?

The FDA 510(k) record lists Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Video Endoscopy System, 3D Video Endoscopy System?

The FDA product code for Video Endoscopy System, 3D Video Endoscopy System is HET.

其他以 Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. 為申請人之記錄

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。

K240376電穿孔系統（N3000）K221995氣體充填器 K212614超音波刀系統 K210488超聲外科與電外科發生器 K183153微波消融系統 K190052無線頻率消融系統

查看所有 7 項裝置 →

相關器械（代碼：HET）

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。

K250939SIRIUS內視鏡系統（PR-SI-1230）Precision Robotics (Hong Kong) Limited K243821i-CutA.M.I. Agency For Medical Innovations GmbH K221642SIRIUS內視鏡系統Precision Robotics (Hong Kong) Limited K201832Endoeye Flex 可變向視鏡與利康 LTF-S190-5Olympus Medical Systems Corp.K210104SurroundScope 系統270surgical , Ltd.K201617TipVision視覺內視鏡系統（TipVision VideoScope 0°/30°；EleVision HD 2 開關控制單元（CCU））Schoelly Fiberoptic GmbH

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。