Biliary Stent System For Benign Strictures
The Biliary Stent System For Benign Strictures (product code PNB) is a Class 2 gastroenterology and urology prescription device intended for treatment of benign biliary strictures, regulated under 876.5011. It consists of a metal stent and a delivery system for placing the stent in the biliary ducts; stents are intended to be left indwelling for a limited period and subsequently removed. The device is flagged as an implant and requires 510(k) clearance.
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Basic Information
- Product Code
- PNB
- Device Class
- FDA class 2
- Regulation Number
- 876.5011
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
Definition
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN150040 | WallFlex Biliary RX Fully Covered Stent System RMV | Jun 03, 2016 | Unknown | Boston Scientific |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.