FDA 510(k)

靈活式視覺輸尿管腎鏡SSU系統

K 號：K212458 · 2022-01-20

決定日期2022-01-20

產品代碼FGB

諮詢委員會GU

決定相當於

器材摘要

Flexible Video-Uretero-Renoscope SSU System is the device name listed in this FDA 510(k) record. The listed applicant is Karl Storz Endoscopy America. It received FDA 510(k) clearance on 2022-01-20 under 510(k) number K212458. 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-Uretero-Renoscope SSU System?

Flexible Video-Uretero-Renoscope SSU System is a medical device that received FDA 510(k) clearance on 2022-01-20. The listed applicant is Karl Storz Endoscopy America. The 510(k) number is K212458.

When did Flexible Video-Uretero-Renoscope SSU System receive FDA 510(k) clearance?

Flexible Video-Uretero-Renoscope SSU System received FDA 510(k) clearance on 2022-01-20, under 510(k) number K212458.

Who is the listed applicant for Flexible Video-Uretero-Renoscope SSU System?

The FDA 510(k) record lists Karl Storz Endoscopy America as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Flexible Video-Uretero-Renoscope SSU System?

The FDA product code for Flexible Video-Uretero-Renoscope SSU System is FGB.

其他以 Karl Storz Endoscopy America 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。

K212656靈活導管視覺內鏡 – 無菌（FIVE-S）K212695卡爾史托茲內視鏡成像系統 K201001Modulith SLX-F2 K201526TIPCAM1 Rubina 頻道式內視鏡系統

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。