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FDA 510(k)

Proxis Ureteral Access Sheath

K-Number: K160861 · 2016-03-31

ApplicantC.R. Bard, Inc.
Decision Date2016-03-31
Product CodeFED
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Proxis Ureteral Access Sheath is a medical device manufactured by C.R. Bard, Inc.. It received FDA 510(k) clearance on 2016-03-31 under approval number K160861. 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 Proxis Ureteral Access Sheath?

Proxis Ureteral Access Sheath is a medical device that received FDA 510(k) clearance on 2016-03-31. It is manufactured by C.R. Bard, Inc.. The 510(k) number is K160861.

When was Proxis Ureteral Access Sheath approved by the FDA?

Proxis Ureteral Access Sheath received FDA 510(k) clearance on 2016-03-31, under approval number K160861.

What company makes Proxis Ureteral Access Sheath?

Proxis Ureteral Access Sheath is manufactured by C.R. Bard, Inc..

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

The FDA product code for Proxis 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

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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. K151084Well Lead Ureteral Access SheathWell Lead Medical Co., Ltd. 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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