FDA 510(k)

WiScope OM 経鏡系統，WiScope 單次使用數字柔軟輸尿管鏡。總管鏡，WiScope 圖像系統

K 號：K210579 · 2021-07-22

決定日期2021-07-22

產品代碼FGB

諮詢委員會GU

決定相當於

器材摘要

WiScope OM Endoscope System, WiScope Single-Use Digital Flexible Ureteroscope.Choledochoscope, WiScope Image System is the device name listed in this FDA 510(k) record. The listed applicant is OTU Medical, Inc.. It received FDA 510(k) clearance on 2021-07-22 under 510(k) number K210579. The device is classified under product code FGB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the WiScope OM Endoscope System, WiScope Single-Use Digital Flexible Ureteroscope.Choledochoscope, WiScope Image System?

WiScope OM Endoscope System, WiScope Single-Use Digital Flexible Ureteroscope.Choledochoscope, WiScope Image System is a medical device that received FDA 510(k) clearance on 2021-07-22. The listed applicant is OTU Medical, Inc.. The 510(k) number is K210579.

When did WiScope OM Endoscope System, WiScope Single-Use Digital Flexible Ureteroscope.Choledochoscope, WiScope Image System receive FDA 510(k) clearance?

WiScope OM Endoscope System, WiScope Single-Use Digital Flexible Ureteroscope.Choledochoscope, WiScope Image System received FDA 510(k) clearance on 2021-07-22, under 510(k) number K210579.

Who is the listed applicant for WiScope OM Endoscope System, WiScope Single-Use Digital Flexible Ureteroscope.Choledochoscope, WiScope Image System?

The FDA 510(k) record lists OTU Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WiScope OM Endoscope System, WiScope Single-Use Digital Flexible Ureteroscope.Choledochoscope, WiScope Image System?

The FDA product code for WiScope OM Endoscope System, WiScope Single-Use Digital Flexible Ureteroscope.Choledochoscope, WiScope Image System is FGB.

其他以 OTU Medical, Inc. 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。

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相關器械（代碼：FGB）

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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