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FDA 510(k)

Well Lead Ureteral Access Sheath

K-Number: K151084 · 2016-01-07

ApplicantWell Lead Medical Co., Ltd.
Decision Date2016-01-07
Product CodeFED
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Well Lead Ureteral Access Sheath is a medical device manufactured by Well Lead Medical Co., Ltd.. It received FDA 510(k) clearance on 2016-01-07 under approval number K151084. 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 Well Lead Ureteral Access Sheath?

Well Lead Ureteral Access Sheath is a medical device that received FDA 510(k) clearance on 2016-01-07. It is manufactured by Well Lead Medical Co., Ltd.. The 510(k) number is K151084.

When was Well Lead Ureteral Access Sheath approved by the FDA?

Well Lead Ureteral Access Sheath received FDA 510(k) clearance on 2016-01-07, under approval number K151084.

What company makes Well Lead Ureteral Access Sheath?

Well Lead Ureteral Access Sheath is manufactured by Well Lead Medical Co., Ltd..

What is the FDA product code for Well Lead Ureteral Access Sheath?

The FDA product code for Well Lead Ureteral Access Sheath is FED.

Related Clinical Trials

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

Other Devices by Well Lead Medical Co., Ltd.

K160801Well Lead Extraction Bag K161110ClearPetra Suction-Evacuation Sheath K162340Stomach Tube K182739Endotracheal Tube with Evacuation Lumen K203119ClearPetra Suction-Evacuation Sheath K202134Well Lead All Silicone Foley Catheter with Temperature Sensor

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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. K172217Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access SheathCook Incorporated K181811ReTrace Ureteral Access SheathColoplast A/S

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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