Ureteral Access Sheath
K-Number: K250132 · 2025-09-05
Decision Date2025-09-05
Product CodeFED
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Ureteral Access Sheath is a medical device manufactured by Zhejiang YiGao Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-09-05 under approval number K250132. 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 Ureteral Access Sheath?
Ureteral Access Sheath is a medical device that received FDA 510(k) clearance on 2025-09-05. It is manufactured by Zhejiang YiGao Medical Technology Co., Ltd.. The 510(k) number is K250132.
When was Ureteral Access Sheath approved by the FDA?
Ureteral Access Sheath received FDA 510(k) clearance on 2025-09-05, under approval number K250132.
What company makes Ureteral Access Sheath?
Ureteral Access Sheath is manufactured by Zhejiang YiGao Medical Technology Co., Ltd..
What is the FDA product code for Ureteral Access Sheath?
The FDA product code for Ureteral Access Sheath is FED.
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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.