Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Single-use Ureteral Access Sheath

K-Number: K250695 · 2025-07-08

ApplicantShenzhen HugeMed Medical Technical Development Co., Ltd.
Decision Date2025-07-08
Product CodeFED
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Single-use Ureteral Access Sheath is a medical device manufactured by Shenzhen HugeMed Medical Technical Development Co., Ltd.. It received FDA 510(k) clearance on 2025-07-08 under approval number K250695. 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 Ureteral Access Sheath?

Single-use Ureteral Access Sheath is a medical device that received FDA 510(k) clearance on 2025-07-08. It is manufactured by Shenzhen HugeMed Medical Technical Development Co., Ltd.. The 510(k) number is K250695.

When was Single-use Ureteral Access Sheath approved by the FDA?

Single-use Ureteral Access Sheath received FDA 510(k) clearance on 2025-07-08, under approval number K250695.

What company makes Single-use Ureteral Access Sheath?

Single-use Ureteral Access Sheath is manufactured by Shenzhen HugeMed Medical Technical Development Co., Ltd..

What is the FDA product code for Single-use Ureteral Access Sheath?

The FDA product code for Single-use Ureteral Access Sheath is FED.

Related Clinical Trials

NCT07372872 Feasibility Testing of the "MyGlucoCare" Smartphone App for Women With Gestational Diabetes RECRUITING NCT07599085 Early Feasibility Study to Assess the Safety and Effectiveness of the OnePoint Dialysis CannulaTM as a Single-Site Vascular Access Device for Hemodialysis Procedures NOT_YET_RECRUITING NCT06495996 The Protrieve PROTECTOR Study COMPLETED NCT07567456 Pulsatile Flushing Technique in Reducing Blockage of T-CVAD for Haemodialysis Patients RECRUITING NCT07380516 Xo-Motion R Exoskeleton in SCI-Adoption Study NOT_YET_RECRUITING NCT04484220 Ellipsys Vascular Access System Post Market Surveillance (PS) Study COMPLETED

Other Devices by Shenzhen HugeMed Medical Technical Development Co., Ltd.

K231118Cystoscope System K222910Bronchoscope System K240374Ureterorenoscope System K232435Rhinolaryngoscope system K231497Choledochoscope System K241444Biliary Pancreaticobiliary Scope System

View all 8 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.

↑