FDA 510(k)

Ureteral Dilators and Percutaneous Nephrostomy Dilators

K-Number: K170531 · 2017-08-17

Decision Date2017-08-17

Product CodeEZN

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Ureteral Dilators and Percutaneous Nephrostomy Dilators is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast Corp.. It received FDA 510(k) clearance on 2017-08-17 under 510(k) 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. The listed applicant is Coloplast Corp.. The 510(k) number is K170531.

When did Ureteral Dilators and Percutaneous Nephrostomy Dilators receive FDA 510(k) clearance?

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

Who is the listed applicant for Ureteral Dilators and Percutaneous Nephrostomy Dilators?

The FDA 510(k) record lists Coloplast Corp. as the applicant. This does not by itself establish the device manufacturer.

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.

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Related Devices (Code: EZN)

K250910Optilume® High Pressure Urological Balloon Dilation CatheterUrotronic, Inc.K220781ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator, Glider Amplatz Sheath, ARMADA Renal Dilator with Amplatz Sheath, Fascial Dilator Set, Introducer Sheath, Introducer CatheterAllwin Medical Devices, Inc.K201007In-Ka Ureteral Balloon Dilatation CatheterColoplast Corp.K190612EQUINOX Balloon Dilatation CatheterDornier Medtech America, Inc.K173654Ureteral Dilator Sets, Ureteral DilatorsCook Incorporated K180756Safety Wire Guide IntroducerCook Incorporated

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.