FDA 510(k)

靈活式視覺內視鏡系統

K 號：K211686 · 2022-02-22

申請人Shanghai SeeGen Photoelectric Technology Co., Ltd.

決定日期2022-02-22

產品代碼FGB

諮詢委員會GU

決定相當於

器材摘要

Flexible Video-Choledo-Cysto-Ureteroscope System is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai SeeGen Photoelectric Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-02-22 under 510(k) number K211686. 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 Flexible Video-Choledo-Cysto-Ureteroscope System?

Flexible Video-Choledo-Cysto-Ureteroscope System is a medical device that received FDA 510(k) clearance on 2022-02-22. The listed applicant is Shanghai SeeGen Photoelectric Technology Co., Ltd.. The 510(k) number is K211686.

When did Flexible Video-Choledo-Cysto-Ureteroscope System receive FDA 510(k) clearance?

Flexible Video-Choledo-Cysto-Ureteroscope System received FDA 510(k) clearance on 2022-02-22, under 510(k) number K211686.

Who is the listed applicant for Flexible Video-Choledo-Cysto-Ureteroscope System?

The FDA 510(k) record lists Shanghai SeeGen Photoelectric Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Flexible Video-Choledo-Cysto-Ureteroscope System?

The FDA product code for Flexible Video-Choledo-Cysto-Ureteroscope System is FGB.

其他以 Shanghai SeeGen Photoelectric Technology 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。

K252457一次性遠端端 Tape 帽 K243535靈活式內視鏡總管內視鏡（CHV-110J-U）；靈活式內視鏡總管內視鏡（CHV-US120J-U）K241532靈活式視覺總膽囊輸尿管鏡系統（PL-2100）K222499一次性內視鏡閥門組套 K222261靈活式視覺總膽管內視鏡系統

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。

K261447CVAC® 吸引系統Calyxo, Inc.K262488單次使用柔軟性輸尿管鏡（RP-U-C06R9、RP-U-C06R3、RP-U-C06S9、RP-U-C06S3）Guangzhou Red Pine Medical Instrument Co., Ltd.K261153LithoVue Elite數位柔軟輸尿管鏡系統Boston Scientific Corporation K262552單次使用柔軟輸尿管鏡（單次使用柔軟輸尿管鏡：SUV-5C-B）Scivita Medical Technology Co., Ltd.K253505Zamenix™ P 医療設備規範文本 Zamenix™ P 製品於FDA（美國食品藥品管理局）註冊，並通過510(k)認證。該產品屬於PMA（上市前批准）範疇。相關研究於NCT（臨床試驗登錄號）NCTXXXXXXX進行，並在PMID（PubMed ID）XXXXXXX中記錄。產品識別碼為XXXXXXX。相關資訊請參考以下網址：http://www.example.com/zamenix-pRoen Surgical, Inc.K260516泡泡視單次使用數位柔軟膀胱鏡（C38-CS、C38-CRS、C50-C、C50-CR、C50-CB、C50-CBR）MacroLux Medical Technology Co., Ltd.

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。