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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 the device name listed in this FDA 510(k) record. The listed applicant is Cathegenix (Xiamen) Co., Ltd.. It received FDA 510(k) clearance on 2025-06-27 under 510(k) 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. The listed applicant is Cathegenix (Xiamen) Co., Ltd.. The 510(k) number is K250585.

When did LumenaTM Ureteral Access Sheath receive FDA 510(k) clearance?

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

Who is the listed applicant for LumenaTM Ureteral Access Sheath?

The FDA 510(k) record lists Cathegenix (Xiamen) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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.

NCT06547632ClearPetra™ Vacuum-assisted Ureteral Access Sheath vs Traditional ApproachTERMINATEDNCT07072598Comparing Efficiency and Stone-Free Rates Mini PCNL vs Flex URSWITHDRAWNNCT07377461Flexible and Navigable Suction Ureteral Access Sheath (FANS) vs Conventional Access Sheaths in RIRS: A Prospective Randomized Study.COMPLETEDNCT07568990Ureteral Access Sheaths in Endoscopic Kidney Stone SurgeryRECRUITINGNCT07655050Antibiotic Irrigation and Suction Ureteral Access Sheath in RIRSRECRUITINGNCT07678255Access Sheaths With Aspiration for Renal RetrOgrade Surgery, Randomized CompArative OutcomesNOT_YET_RECRUITING

Other records listing Cathegenix (Xiamen) 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.

K251469Endura™ Ureteral Stent and Stent Set

Related Devices (Code: FED)

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.

K260965CVAC Aspiration SystemCalyxo, Inc.K260521ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)Zhuhai Pusen Medical Technology Co., Ltd.K252572Prodeon Urethral Sheath SystemProdeon Medical, Inc.K250128Single Use Suction-Evacuation Ureteral Access SheathAnhui Happiness Workshop Medical Instruments Co., Ltd.K250132Ureteral Access SheathZhejiang YiGao Medical Technology Co., Ltd.K250695Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.

Official Source

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

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