FDA 510(k)

Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video Ureteroscope (PU3033H, PU3033AH)

K番号: K233778 · 2024-07-16

申請者Zhuhai Pusen Medical Technology Co., Ltd.

決定日2024-07-16

製品コードFGB

諮問委員会以下は、指定された医療機器規制テキストの日本語訳です。以下の医療機器規制テキストを日本語に翻訳してください。会社名、製品名、FDA、510(k)、PMA、NCT、PMID、識別子、およびURLを保護してください。ポリシー：medical-regulatory-v1 [原文] GU [翻訳] GU

決定Substantially Equivalent

医療機器の概要

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.

よくある質問

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.

申請者としてZhuhai Pusen Medical Technology Co., Ltd.を記載するその他の記録

K260521クリアエヴァック尿管吸引アクセスシート（PUS-100-1040、PUS-100-1050、PUS-100-1240、PUS-100-1250）K223741Pusen Single Use Flexible Video Cystoscope/Choledochoscope System (Single Use Flexible Video Cystoscope/Choledochoscope:PC200-AS, PC200-AR, PC200-S and PC200-R;HD Medical Video Endoscope Image Processor: PV300)K222602Pusen Single Use Flexible Video Cystoscope System (Single Use Flexible Video Cystoscope: PC200-AS, PC200-AR, PC200-S and PC200-R; HD Medical Video Endoscope Image Processor: PV300)K190648Pusen Eview Medical Video Endoscope Image Processor K172098Medical Video Endoscope System K171076Medical Video Endoscope System

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