510(k) DEN150040
DEN150040 is an FDA 510(k) premarket notification submitted by Boston Scientific for the device "WallFlex Biliary RX Fully Covered Stent System RMV". The FDA issued a decision of De Novo Granted on June 3, 2016. The device falls under product code PNB (Biliary Stent System For Benign Strictures), a Class II device regulated under 21 CFR 876.5011. Boston Scientific has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- June 3, 2016
- Date Received
- August 28, 2015
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Biliary Stent System For Benign Strictures
- Device Class
- Class II
- Regulation Number
- 876.5011
- Review Panel
- GU
- Submission Type
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.