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)

Disposable Ureteral Access Sheath

K-Number: K230748 · 2023-08-02

ApplicantYoucare Technology Co.,Ltd. (Wuhan)
Decision Date2023-08-02
Product CodeFED
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Disposable Ureteral Access Sheath is a medical device manufactured by Youcare Technology Co.,Ltd. (Wuhan). It received FDA 510(k) clearance on 2023-08-02 under approval number K230748. 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 Disposable Ureteral Access Sheath?

Disposable Ureteral Access Sheath is a medical device that received FDA 510(k) clearance on 2023-08-02. It is manufactured by Youcare Technology Co.,Ltd. (Wuhan). The 510(k) number is K230748.

When was Disposable Ureteral Access Sheath approved by the FDA?

Disposable Ureteral Access Sheath received FDA 510(k) clearance on 2023-08-02, under approval number K230748.

What company makes Disposable Ureteral Access Sheath?

Disposable Ureteral Access Sheath is manufactured by Youcare Technology Co.,Ltd. (Wuhan).

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

The FDA product code for Disposable Ureteral Access Sheath is FED.

Related Clinical Trials

NCT07228117 GATEWAY: Safety Evaluation of the MiniMed™ NMX8-AID System in Children and Adults Living With Diabetes RECRUITING 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 NCT07355400 Clinical Evaluation of the NeoPill Device for Reduction of Oral Bacterial Load in Patients With Fixed Orthodontic Appliances RECRUITING

Other Devices by Youcare Technology Co.,Ltd. (Wuhan)

K222705Introducer Needle

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.

↑