FDA 510(k)

WiScope數位膀胱鏡系統，WiScope一次性使用數位柔軟膀胱鏡，WiScope影像系統

K 號：K212202 · 2022-04-13

決定日期2022-04-13

產品代碼FAJ

諮詢委員會GU

決定相當於

器材摘要

WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope, 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 2022-04-13 under 510(k) number K212202. The device is classified under product code FAJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope, WiScope Image System?

WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope, WiScope Image System is a medical device that received FDA 510(k) clearance on 2022-04-13. The listed applicant is OTU Medical, Inc.. The 510(k) number is K212202.

When did WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope, WiScope Image System receive FDA 510(k) clearance?

WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope, WiScope Image System received FDA 510(k) clearance on 2022-04-13, under 510(k) number K212202.

Who is the listed applicant for WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope, 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 Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope, WiScope Image System?

The FDA product code for WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope, WiScope Image System is FAJ.

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。

K231702WiScope®數位膀胱鏡系統，WiScope®一次性使用數位柔軟膀胱鏡，WiScope®醫療平板電腦 K220399WiScope數位支氣管內鏡系統，WiScope一次性使用數位柔軟支氣管內鏡，WiScope影像系統 K210579WiScope 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 K181977WiScope數位內視鏡系統

相關器械（代碼：FAJ）

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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