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FDA 510(k)

Universa Soft Ureteral Stents and Stent Sets

K-Number: K151051 · 2016-01-11

ApplicantCook Incorporated
Decision Date2016-01-11
Product CodeFAD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Universa Soft Ureteral Stents and Stent Sets is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2016-01-11 under approval number K151051. The device is classified under product code FAD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Universa Soft Ureteral Stents and Stent Sets?

Universa Soft Ureteral Stents and Stent Sets is a medical device that received FDA 510(k) clearance on 2016-01-11. It is manufactured by Cook Incorporated. The 510(k) number is K151051.

When was Universa Soft Ureteral Stents and Stent Sets approved by the FDA?

Universa Soft Ureteral Stents and Stent Sets received FDA 510(k) clearance on 2016-01-11, under approval number K151051.

What company makes Universa Soft Ureteral Stents and Stent Sets?

Universa Soft Ureteral Stents and Stent Sets is manufactured by Cook Incorporated.

What is the FDA product code for Universa Soft Ureteral Stents and Stent Sets?

The FDA product code for Universa Soft Ureteral Stents and Stent Sets is FAD.

Related Clinical Trials

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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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