PNB · Class II · 21 CFR 876.5011

FDA Product Code PNB: Biliary Stent System For Benign Strictures

A Benign Stricture Biliary Stent System Is A Prescription Device Intended For Treatment Of Benign Biliary Strictures. Stents Are Intended To Be Left Indwelling For A Limited Amount Of Time And Subsequently Removed. The Device Consists Of A Metal Stent And A Delivery System Intended To Place The Stent In The Biliary Ducts.

Leading manufacturers include Boston Scientific.

1
Total
0
Cleared
280d
Avg days
2016
Since

FDA 510(k) Cleared Biliary Stent System For Benign Strictures Devices (Product Code PNB)

1 devices
1–1 of 1
Not Cleared Jun 03, 2016
WallFlex Biliary RX Fully Covered Stent System RMV
DEN150040
Boston Scientific
Gastroenterology & Urology · 280d

About Product Code PNB - Regulatory Context