ConvertX Nephroureteral Stent System

Stent, Ureteral

BRIGHTWATER MEDICAL

The following data is part of a premarket notification filed by Brightwater Medical with the FDA for Convertx Nephroureteral Stent System.

Pre-market Notification Details

Device IDK161277
510k NumberK161277
Device Name:ConvertX Nephroureteral Stent System
ClassificationStent, Ureteral
Applicant BRIGHTWATER MEDICAL 816 W. BENNETT CT. Dunlap,  IL  61525
ContactBob Smouse
CorrespondentBob Smouse
BRIGHTWATER MEDICAL 816 W. BENNETT CT. Dunlap,  IL  61525
Product CodeFAD  
CFR Regulation Number876.4620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-05-06
Decision Date2016-11-22
Summary:summary

NIH GUDID Devices

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