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FDA 510(k)

RenaFlex單次使用柔軟輸尿管鏡（SUURF-V標準型）；RenaFlex單次使用柔軟輸尿管鏡（SUURF-VR反向型）；單次使用內鏡視頻系統中心（CV-S1）

K 號：K233275 · 2024-03-25

申請人Gyrus Acmi, Inc.
決定日期2024-03-25
產品代碼FGB
諮詢委員會GU
決定相當於

器材摘要

RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard); RenaFlex Single-use Flexible Ureteroscope (SUURF-VR Reverse); Video System Center for Single-use Endoscopes (CV-S1) is the device name listed in this FDA 510(k) record. The listed applicant is Gyrus Acmi, Inc.. It received FDA 510(k) clearance on 2024-03-25 under 510(k) number K233275. 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 RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard); RenaFlex Single-use Flexible Ureteroscope (SUURF-VR Reverse); Video System Center for Single-use Endoscopes (CV-S1)?

RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard); RenaFlex Single-use Flexible Ureteroscope (SUURF-VR Reverse); Video System Center for Single-use Endoscopes (CV-S1) is a medical device that received FDA 510(k) clearance on 2024-03-25. The listed applicant is Gyrus Acmi, Inc.. The 510(k) number is K233275.

When did RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard); RenaFlex Single-use Flexible Ureteroscope (SUURF-VR Reverse); Video System Center for Single-use Endoscopes (CV-S1) receive FDA 510(k) clearance?

RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard); RenaFlex Single-use Flexible Ureteroscope (SUURF-VR Reverse); Video System Center for Single-use Endoscopes (CV-S1) received FDA 510(k) clearance on 2024-03-25, under 510(k) number K233275.

Who is the listed applicant for RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard); RenaFlex Single-use Flexible Ureteroscope (SUURF-VR Reverse); Video System Center for Single-use Endoscopes (CV-S1)?

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

What is the FDA product code for RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard); RenaFlex Single-use Flexible Ureteroscope (SUURF-VR Reverse); Video System Center for Single-use Endoscopes (CV-S1)?

The FDA product code for RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard); RenaFlex Single-use Flexible Ureteroscope (SUURF-VR Reverse); Video System Center for Single-use Endoscopes (CV-S1) is FGB.

相關臨床試驗

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NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Gyrus Acmi, 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。

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 CorporationK262552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

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