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FDA 510(k)

Single Use Suction-Evacuation Ureteral Access Sheath

K-Number: K250128 · 2025-09-19

ApplicantAnhui Happiness Workshop Medical Instruments Co., Ltd.
Decision Date2025-09-19
Product CodeFED
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Single Use Suction-Evacuation Ureteral Access Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Anhui Happiness Workshop Medical Instruments Co., Ltd.. It received FDA 510(k) clearance on 2025-09-19 under 510(k) number K250128. 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 Single Use Suction-Evacuation Ureteral Access Sheath?

Single Use Suction-Evacuation Ureteral Access Sheath is a medical device that received FDA 510(k) clearance on 2025-09-19. The listed applicant is Anhui Happiness Workshop Medical Instruments Co., Ltd.. The 510(k) number is K250128.

When did Single Use Suction-Evacuation Ureteral Access Sheath receive FDA 510(k) clearance?

Single Use Suction-Evacuation Ureteral Access Sheath received FDA 510(k) clearance on 2025-09-19, under 510(k) number K250128.

Who is the listed applicant for Single Use Suction-Evacuation Ureteral Access Sheath?

The FDA 510(k) record lists Anhui Happiness Workshop Medical Instruments Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Single Use Suction-Evacuation Ureteral Access Sheath?

The FDA product code for Single Use Suction-Evacuation 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.

NCT07377461Flexible and Navigable Suction Ureteral Access Sheath (FANS) vs Conventional Access Sheaths in RIRS: A Prospective Randomized Study.COMPLETEDNCT07655050Antibiotic Irrigation and Suction Ureteral Access Sheath in RIRSRECRUITINGNCT07072598Comparing Efficiency and Stone-Free Rates Mini PCNL vs Flex URSRECRUITINGNCT07685587COMPARISON OF FANS VS CONVENTIONAL URETERAL ACCESS SHEATH in RIRS on POSTOPERATIVE ACUTE KIDNEY INJURYRECRUITINGNCT07689565Standard Versus Flexible and Navigable Suction Ureteral Access Sheath in Pediatric Flexible Ureterorenoscopy for Renal Stones < 2 cmNOT_YET_RECRUITINGNCT07087977HoYAG vs TFL in miniPCNL With ClearPetraRECRUITING

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.K250132Ureteral Access SheathZhejiang YiGao Medical Technology Co., Ltd.K250695Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.K251599Single-use Ureteral Access SheathHunan Vathin Medical Instrument Co., Ltd.

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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