FDA 510(k)

單次使用吸引式輸尿管內視鏡（PU400A，PU411A），單次使用柔軟式視頻輸尿管內視鏡（PU3033H，PU3033AH）

K 號：K233778 · 2024-07-16

申請人Zhuhai Pusen Medical Technology Co., Ltd.

決定日期2024-07-16

產品代碼FGB

諮詢委員會GU

決定相當於

器材摘要

Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video Ureteroscope (PU3033H, PU3033AH) is the device name listed in this FDA 510(k) record. The listed applicant is Zhuhai Pusen Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-07-16 under 510(k) number K233778. 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 Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video Ureteroscope (PU3033H, PU3033AH)?

Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video Ureteroscope (PU3033H, PU3033AH) is a medical device that received FDA 510(k) clearance on 2024-07-16. The listed applicant is Zhuhai Pusen Medical Technology Co., Ltd.. The 510(k) number is K233778.

When did Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video Ureteroscope (PU3033H, PU3033AH) receive FDA 510(k) clearance?

Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video Ureteroscope (PU3033H, PU3033AH) received FDA 510(k) clearance on 2024-07-16, under 510(k) number K233778.

Who is the listed applicant for Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video Ureteroscope (PU3033H, PU3033AH)?

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

What is the FDA product code for Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video Ureteroscope (PU3033H, PU3033AH)?

The FDA product code for Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video Ureteroscope (PU3033H, PU3033AH) is FGB.

其他以 Zhuhai Pusen 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。

K260521ClearEVAC 腎管吸引進入鞘 (PUS-100-1040, PUS-100-1050, PUS-100-1240, PUS-100-1250)K223741Pusen單次使用柔軟式電子膀胱鏡/總膽管鏡系統（單次使用柔軟式電子膀胱鏡/總膽管鏡：PC200-AS、PC200-AR、PC200-S及PC200-R；HD醫學電子內視鏡影像處理器：PV300）K222602Pusen單次使用柔軟式電子膀胱鏡系統（單次使用柔軟式電子膀胱鏡：PC200-AS、PC200-AR、PC200-S及PC200-R；HD醫學電子內視鏡影像處理器：PV300）K190648普森Eview醫療內視鏡影像處理器 K172098醫學內視鏡系統 K171076醫學內視鏡系統

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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 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

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