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FDA 510(k)

ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)

K-Number: K260521 · 2026-04-06

ApplicantZhuhai Pusen Medical Technology Co., Ltd.
Decision Date2026-04-06
Product CodeFED
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250) is a medical device manufactured by Zhuhai Pusen Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-04-06 under approval number K260521. The device is classified under product code FED. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)?

ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250) is a medical device that received FDA 510(k) clearance on 2026-04-06. It is manufactured by Zhuhai Pusen Medical Technology Co., Ltd.. The 510(k) number is K260521.

When was ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250) approved by the FDA?

ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250) received FDA 510(k) clearance on 2026-04-06, under approval number K260521.

What company makes ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)?

ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250) is manufactured by Zhuhai Pusen Medical Technology Co., Ltd..

What is the FDA product code for ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)?

The FDA product code for ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250) is FED.

Related Clinical Trials

NCT07568990 Ureteral Access Sheaths in Endoscopic Kidney Stone Surgery NOT_YET_RECRUITING NCT06547632 ClearPetra™ Vacuum-assisted Ureteral Access Sheath vs Traditional Approach TERMINATED NCT07072598 Comparing Efficiency and Stone-Free Rates Mini PCNL vs Flex URS RECRUITING

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

K172098Medical Video Endoscope System 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)

View all 7 devices →

Related Devices (Code: FED)

K162205Arc EndoCuff and Arc EndoCuff VisionBoddingtons Plastics, Ltd. K161110ClearPetra Suction-Evacuation SheathWell Lead Medical Co., Ltd. K160846AmplifEYEMedivators, Inc. K160861Proxis Ureteral Access SheathC.R. Bard, Inc. K151084Well Lead Ureteral Access SheathWell Lead Medical Co., Ltd. K172217Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access SheathCook Incorporated

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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