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FDA 510(k)

LumenaTM Ureteral Access Sheath

K-Number: K250585 · 2025-06-27

ApplicantCathegenix (Xiamen) Co., Ltd.
Decision Date2025-06-27
Product CodeFED
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LumenaTM Ureteral Access Sheath is a medical device manufactured by Cathegenix (Xiamen) Co., Ltd.. It received FDA 510(k) clearance on 2025-06-27 under approval number K250585. 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 LumenaTM Ureteral Access Sheath?

LumenaTM Ureteral Access Sheath is a medical device that received FDA 510(k) clearance on 2025-06-27. It is manufactured by Cathegenix (Xiamen) Co., Ltd.. The 510(k) number is K250585.

When was LumenaTM Ureteral Access Sheath approved by the FDA?

LumenaTM Ureteral Access Sheath received FDA 510(k) clearance on 2025-06-27, under approval number K250585.

What company makes LumenaTM Ureteral Access Sheath?

LumenaTM Ureteral Access Sheath is manufactured by Cathegenix (Xiamen) Co., Ltd..

What is the FDA product code for LumenaTM Ureteral Access Sheath?

The FDA product code for LumenaTM 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 Cathegenix (Xiamen) Co., Ltd.

K251469Endura™ Ureteral Stent and Stent Set

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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