FDA 510(k)

ConvertX Nephroureteral Stent System

K-Number: K161277 · 2016-11-22

Decision Date2016-11-22

Product CodeFAD

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

ConvertX Nephroureteral Stent System is a medical device manufactured by Brightwater Medical. It received FDA 510(k) clearance on 2016-11-22 under approval number K161277. 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 ConvertX Nephroureteral Stent System?

ConvertX Nephroureteral Stent System is a medical device that received FDA 510(k) clearance on 2016-11-22. It is manufactured by Brightwater Medical. The 510(k) number is K161277.

When was ConvertX Nephroureteral Stent System approved by the FDA?

ConvertX Nephroureteral Stent System received FDA 510(k) clearance on 2016-11-22, under approval number K161277.

What company makes ConvertX Nephroureteral Stent System?

ConvertX Nephroureteral Stent System is manufactured by Brightwater Medical.

What is the FDA product code for ConvertX Nephroureteral Stent System?

The FDA product code for ConvertX Nephroureteral Stent System is FAD.

Related Clinical Trials

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Other Devices by Brightwater Medical

K181669ConvertX Biliary Stent System

Related Devices (Code: FAD)

K163068pAguaMedicina PERSISTENT Structural Hydrogel Ureteral StentQ Urological Corporation K160891Ultrathane Endoureterotomy Stent SetCook Incorporated K151051Universa Soft Ureteral Stents and Stent SetsCook Incorporated K170362VORTEK HYDRO-COATED DOUBLE LOOP URETERAL STENTSColoplast Corp. K170422BIOSOFT DUO DOUBLE LOOP URETERAL STENTSColoplast Corp. K172289pAguaMedicina PERSISTENT Structural Hydrogel Ureteral StentQ Urological Corporation

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.