免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料，僅供一般參考，不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

泌尿內視鏡系統（單次使用柔軟輸尿管鏡：SUV-1A-B、SUV-1A-P、SUV-2A-B、SUV-2A-P、SUV-2B-B、SUB-2B-P、SUV-2C-B、SUV-2C-P；單次使用柔軟膀胱鏡：SUV-1D-B、SUV-1D-P；內視鏡圖像處理器：HDVS-S100A、HDVS-S100D。）

K 號：K243708 · 2025-03-27

申請人Scivita Medical Technology Co., Ltd.
決定日期2025-03-27
產品代碼FGB
諮詢委員會GU
決定相當於

器材摘要

Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-2A-P, SUV-2B-B, SUB-2B-P, SUV-2C-B, SUV-2C-P;Single-use Flexible Cystoscope: SUV-1D-B, SUV-1D-P; Endoscopic Image Processor: HDVS-S100A, HDVS-S100D.) is the device name listed in this FDA 510(k) record. The listed applicant is Scivita Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-03-27 under 510(k) number K243708. 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 Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-2A-P, SUV-2B-B, SUB-2B-P, SUV-2C-B, SUV-2C-P;Single-use Flexible Cystoscope: SUV-1D-B, SUV-1D-P; Endoscopic Image Processor: HDVS-S100A, HDVS-S100D.)?

Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-2A-P, SUV-2B-B, SUB-2B-P, SUV-2C-B, SUV-2C-P;Single-use Flexible Cystoscope: SUV-1D-B, SUV-1D-P; Endoscopic Image Processor: HDVS-S100A, HDVS-S100D.) is a medical device that received FDA 510(k) clearance on 2025-03-27. The listed applicant is Scivita Medical Technology Co., Ltd.. The 510(k) number is K243708.

When did Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-2A-P, SUV-2B-B, SUB-2B-P, SUV-2C-B, SUV-2C-P;Single-use Flexible Cystoscope: SUV-1D-B, SUV-1D-P; Endoscopic Image Processor: HDVS-S100A, HDVS-S100D.) receive FDA 510(k) clearance?

Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-2A-P, SUV-2B-B, SUB-2B-P, SUV-2C-B, SUV-2C-P;Single-use Flexible Cystoscope: SUV-1D-B, SUV-1D-P; Endoscopic Image Processor: HDVS-S100A, HDVS-S100D.) received FDA 510(k) clearance on 2025-03-27, under 510(k) number K243708.

Who is the listed applicant for Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-2A-P, SUV-2B-B, SUB-2B-P, SUV-2C-B, SUV-2C-P;Single-use Flexible Cystoscope: SUV-1D-B, SUV-1D-P; Endoscopic Image Processor: HDVS-S100A, HDVS-S100D.)?

FDA 510(k) 記錄將 Scivita Medical Technology Co., Ltd. 列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-2A-P, SUV-2B-B, SUB-2B-P, SUV-2C-B, SUV-2C-P;Single-use Flexible Cystoscope: SUV-1D-B, SUV-1D-P; Endoscopic Image Processor: HDVS-S100A, HDVS-S100D.)?

The FDA product code for Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-2A-P, SUV-2B-B, SUB-2B-P, SUV-2C-B, SUV-2C-P;Single-use Flexible Cystoscope: SUV-1D-B, SUV-1D-P; Endoscopic Image Processor: HDVS-S100A, HDVS-S100D.) is FGB.

相關臨床試驗

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。

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 Scivita Medical 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。

K262552單次使用柔軟輸尿管鏡（單次使用柔軟輸尿管鏡：SUV-5C-B）K251338肝管內視鏡視覺化系統（一次性視覺肝管內視鏡：SCV-P-01G，SCV-P-02G；全高清內視鏡影像處理器：HDVS-S300A，HDVS-S300B，HDVS-S300C，HDVS-S300D）K250210bronchovideoscope系統（單次使用支氣管內視鏡（SBV-1A-B、SBV-1A-P、SBV-1B-B、SBV-1B-P、SBV-1C-B、SBV-1C-P）；全高清內視鏡影像處理器（HDVS-S300A、HDVS-S300B、HDVS-S300C、HDVS-S300D）；內視鏡影像處理器（HDVS-S100A、HDVS-S100D））K240289全高清內視鏡影像處理器（HDVS-S200A、HDVS-S200B、HDVS-S200C、HDVS-S200D）K240192單次使用抽提籃K231521bronchovideoscope 系統

查看所有 13 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 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

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。

↑