Disposable Ureteral Guide Sheath
K-Number: K241181 · 2024-08-02
Decision Date2024-08-02
Product CodeFED
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Disposable Ureteral Guide Sheath is a medical device manufactured by Dongguan Zsr Biomedical Technology Company Limited. It received FDA 510(k) clearance on 2024-08-02 under approval number K241181. 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 Guide Sheath?
Disposable Ureteral Guide Sheath is a medical device that received FDA 510(k) clearance on 2024-08-02. It is manufactured by Dongguan Zsr Biomedical Technology Company Limited. The 510(k) number is K241181.
When was Disposable Ureteral Guide Sheath approved by the FDA?
Disposable Ureteral Guide Sheath received FDA 510(k) clearance on 2024-08-02, under approval number K241181.
What company makes Disposable Ureteral Guide Sheath?
Disposable Ureteral Guide Sheath is manufactured by Dongguan Zsr Biomedical Technology Company Limited.
What is the FDA product code for Disposable Ureteral Guide Sheath?
The FDA product code for Disposable Ureteral Guide Sheath is FED.
Related Clinical Trials
NCT07173309
Evaluation of Eye Gaze Sharing in the Operating Room
RECRUITING
NCT07174479
Eye Gaze Guidance Evaluation in Phantoms
COMPLETED
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
NCT07161024
AR Projections for Eye-gaze Evaluation in Phantoms
COMPLETED
Other Devices by Dongguan Zsr Biomedical Technology Company Limited
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.