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FDA 510(k)

Ureteral Dilators and Percutaneous Nephrostomy Dilators

K-Number: K170531 · 2017-08-17

ApplicantColoplast Corp.
Decision Date2017-08-17
Product CodeEZN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Ureteral Dilators and Percutaneous Nephrostomy Dilators is a medical device manufactured by Coloplast Corp.. It received FDA 510(k) clearance on 2017-08-17 under approval number K170531. The device is classified under product code EZN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ureteral Dilators and Percutaneous Nephrostomy Dilators?

Ureteral Dilators and Percutaneous Nephrostomy Dilators is a medical device that received FDA 510(k) clearance on 2017-08-17. It is manufactured by Coloplast Corp.. The 510(k) number is K170531.

When was Ureteral Dilators and Percutaneous Nephrostomy Dilators approved by the FDA?

Ureteral Dilators and Percutaneous Nephrostomy Dilators received FDA 510(k) clearance on 2017-08-17, under approval number K170531.

What company makes Ureteral Dilators and Percutaneous Nephrostomy Dilators?

Ureteral Dilators and Percutaneous Nephrostomy Dilators is manufactured by Coloplast Corp..

What is the FDA product code for Ureteral Dilators and Percutaneous Nephrostomy Dilators?

The FDA product code for Ureteral Dilators and Percutaneous Nephrostomy Dilators is EZN.

Related Clinical Trials

NCT06798753 Occlusion Balloon vs. 5FR Ureteral Catheter COMPLETED

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Related Devices (Code: EZN)

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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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