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FDA 510(k)

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

K-Number: K233778 · 2024-07-16

ApplicantZhuhai Pusen Medical Technology Co., Ltd.
Decision Date2024-07-16
Product CodeFGB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07619456Intrarenal Pressure in Suctioning vs. Non-suctioning SheathsCOMPLETEDNCT07377461Flexible and Navigable Suction Ureteral Access Sheath (FANS) vs Conventional Access Sheaths in RIRS: A Prospective Randomized Study.COMPLETEDNCT06596655Single Use Bronchoscopes for Interventional PulmonologyRECRUITINGNCT07295379LIQUIBAND FIX8® for Ventral Incisional HerniaACTIVE_NOT_RECRUITINGNCT07630155Office-Based Ureteroscopy Utilizing a Single Use Digital, Flexible Ureteroscope for Upper Tract Urothelial CarcinomaRECRUITINGNCT07072598Comparing Efficiency and Stone-Free Rates Mini PCNL vs Flex URSWITHDRAWN

Other records listing Zhuhai Pusen Medical Technology Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260521ClearEVAC Ureteral Aspirating Access Sheath (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 ProcessorK172098Medical Video Endoscope SystemK171076Medical Video Endoscope System

View all 7 devices →

Related Devices (Code: FGB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262552Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)Scivita Medical Technology Co., Ltd.K253505Zamenix™ PRoen Surgical, Inc.K260516BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR)MacroLux Medical Technology Co., Ltd.K252929Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200)Anhui Happiness Workshop Instruments Co., Ltd.K260013CVAC Image ProcessorCalyxo, Inc.K252468Single-use Digital Flexible Ureteroscope (GY-UR9.3); Single-use Digital Flexible Ureteroscope (GY-UR8.4); Single-use Digital Flexible Ureteroscope (GY-UR7.5); Endoscope camera system (GY-AIO-121)Zhejiang Geyi Medical Instrument Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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