FDA 510(k)

腎盂鏡系統

K 號：K201293 · 2020-07-24

申請人Shanghai AnQing Medical Instrument Co., Ltd.

決定日期2020-07-24

產品代碼FGB

諮詢委員會GU

決定相當於

器材摘要

Ureterorenoscope System is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai AnQing Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2020-07-24 under 510(k) number K201293. 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 Ureterorenoscope System?

Ureterorenoscope System is a medical device that received FDA 510(k) clearance on 2020-07-24. The listed applicant is Shanghai AnQing Medical Instrument Co., Ltd.. The 510(k) number is K201293.

When did Ureterorenoscope System receive FDA 510(k) clearance?

Ureterorenoscope System received FDA 510(k) clearance on 2020-07-24, under 510(k) number K201293.

Who is the listed applicant for Ureterorenoscope System?

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

What is the FDA product code for Ureterorenoscope System?

The FDA product code for Ureterorenoscope System is FGB.

其他以 Shanghai AnQing Medical Instrument 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。

K254251InnovexView (GC146-17, GC150-20, GC155-23)K252806可彎曲吸引式輸尿管腎盂鏡 (US27G-12-EU, US27G-12-US, US33G-17-EU, US33G-17-US, US38G-20-EU, US38G-20-US.)K252598柔軟膀胱鏡 (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)K251752柔軟性支氣管內視鏡 (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US)K243497可攜式影片處理器（EA101），彈性支氣管內鏡 BS41H-12EU、BS41H-12US、BS46H-17EU、BS50H-20EU、BS46H-17US、BS50H-20US、BS53H-22EU、BS53H-22US、BS55H-24EU、BS55H-24US、BS59H-28EU、BS59H-28US K243857靈活型輸尿管鏡（US27F-12-EU；US27F-12-US）

查看所有 14 項裝置 →

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。