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FDA 510(k)

一次性輸尿管導引鞘

K 號：K241181 · 2024-08-02

申請人Dongguan Zsr Biomedical Technology Company Limited
決定日期2024-08-02
產品代碼FED
諮詢委員會GU
決定相當於

器材摘要

Disposable Ureteral Guide Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Dongguan Zsr Biomedical Technology Company Limited. It received FDA 510(k) clearance on 2024-08-02 under 510(k) number K241181. The device is classified under product code FED. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Disposable Ureteral Guide Sheath?

Disposable Ureteral Guide Sheath is a medical device that received FDA 510(k) clearance on 2024-08-02. The listed applicant is Dongguan Zsr Biomedical Technology Company Limited. The 510(k) number is K241181.

When did Disposable Ureteral Guide Sheath receive FDA 510(k) clearance?

Disposable Ureteral Guide Sheath received FDA 510(k) clearance on 2024-08-02, under 510(k) number K241181.

Who is the listed applicant for Disposable Ureteral Guide Sheath?

The FDA 510(k) record lists Dongguan Zsr Biomedical Technology Company Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Ureteral Guide Sheath?

The FDA product code for Disposable Ureteral Guide Sheath is FED.

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 Dongguan Zsr Biomedical Technology Company Limited 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。

K243155單次使用數位柔軟輸尿管鏡(F-URS)（ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04）

相關器械（代碼：FED）

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。

K260512一次性輸尿管進入鞘Yangzhou Fartley Medical Instrument Technology Co., Ltd.K262262Pathfinder內視鏡外管Neptune Medical, Inc.K260410單次使用輸尿管進入鞘Zhejiang Chuangxiang Medical Technology Co., Ltd.K261915導航™ Flex 腎管進入鞘組合Boston Scientific CorporationK260965CVAC 吸引系統Calyxo, Inc.K260521ClearEVAC 腎管吸引進入鞘 (PUS-100-1040, PUS-100-1050, PUS-100-1240, PUS-100-1250)Zhuhai Pusen Medical Technology Co., Ltd.

官方來源

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