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FDA 510(k)

Ureteral Access Sheath

K-Number: K243025 · 2025-01-30

ApplicantSeplou (Zhuhai) Co., Ltd.
Decision Date2025-01-30
Product CodeFED
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Ureteral Access Sheath is a medical device manufactured by Seplou (Zhuhai) Co., Ltd.. It received FDA 510(k) clearance on 2025-01-30 under approval number K243025. 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 Ureteral Access Sheath?

Ureteral Access Sheath is a medical device that received FDA 510(k) clearance on 2025-01-30. It is manufactured by Seplou (Zhuhai) Co., Ltd.. The 510(k) number is K243025.

When was Ureteral Access Sheath approved by the FDA?

Ureteral Access Sheath received FDA 510(k) clearance on 2025-01-30, under approval number K243025.

What company makes Ureteral Access Sheath?

Ureteral Access Sheath is manufactured by Seplou (Zhuhai) Co., Ltd..

What is the FDA product code for Ureteral Access Sheath?

The FDA product code for Ureteral Access Sheath 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 Seplou (Zhuhai) Co., Ltd.

K250049Medical Video Endoscope [Standard Deflection] (URS3005); Medical Video Endoscope [Reverse Deflection] (URS3005E); Medical Video Endoscope [Standard Deflection] (URS3006); Medical Video Endoscope [Reverse Deflection] (URS3006E); Medical Video Endoscope [Standard Deflection] (URS3016); Medical Video Endoscope [Reverse Deflection] (URS3016E); Image processor (DIS8000)

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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