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FDA 510(k)

Medical Video Endoscope System

K-Number: K172098 · 2017-08-31

ApplicantZhuhai Pusen Medical Technology Co., Ltd.
Decision Date2017-08-31
Product CodeFGB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Medical Video Endoscope System is a medical device manufactured by Zhuhai Pusen Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2017-08-31 under approval number K172098. 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 Medical Video Endoscope System?

Medical Video Endoscope System is a medical device that received FDA 510(k) clearance on 2017-08-31. It is manufactured by Zhuhai Pusen Medical Technology Co., Ltd.. The 510(k) number is K172098.

When was Medical Video Endoscope System approved by the FDA?

Medical Video Endoscope System received FDA 510(k) clearance on 2017-08-31, under approval number K172098.

What company makes Medical Video Endoscope System?

Medical Video Endoscope System is manufactured by Zhuhai Pusen Medical Technology Co., Ltd..

What is the FDA product code for Medical Video Endoscope System?

The FDA product code for Medical Video Endoscope System is FGB.

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Other Devices by Zhuhai Pusen Medical Technology Co., Ltd.

K171076Medical Video Endoscope System K190648Pusen Eview Medical Video Endoscope Image Processor 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) 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) K233778Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video Ureteroscope (PU3033H, PU3033AH) K260521ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)

View all 7 devices →

Related Devices (Code: FGB)

K171076Medical Video Endoscope SystemZhuhai Pusen Medical Technology Co., Ltd. K181977WiScope Digital Endoscope SystemOTU Medical, Inc. K180367Ureterorenoscope SystemShanghai AnQing Medical Instrument Co., Ltd. K172246OLYMPUS URF-V2/V2ROlympus Medical Systems Corp. K172298OLYMPUS URF-P6/P6ROlympus Medical Systems Corp. K183188Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible Sensor-Ureterorenoscopes COBRA Vision EFRichard Wolf Medical Instruments Corporation

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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