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FDA 510(k)

Tria Soft Ureteral Stent

K-Number: K191609 · 2019-08-16

ApplicantBoston Scientific Corporation
Decision Date2019-08-16
Product CodeFAD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Tria Soft Ureteral Stent is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2019-08-16 under approval number K191609. 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 Tria Soft Ureteral Stent?

Tria Soft Ureteral Stent is a medical device that received FDA 510(k) clearance on 2019-08-16. It is manufactured by Boston Scientific Corporation. The 510(k) number is K191609.

When was Tria Soft Ureteral Stent approved by the FDA?

Tria Soft Ureteral Stent received FDA 510(k) clearance on 2019-08-16, under approval number K191609.

What company makes Tria Soft Ureteral Stent?

Tria Soft Ureteral Stent is manufactured by Boston Scientific Corporation.

What is the FDA product code for Tria Soft Ureteral Stent?

The FDA product code for Tria Soft Ureteral Stent is FAD.

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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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