PNB — Biliary Stent System For Benign Strictures Class II
FDA product code PNB covers "Biliary Stent System For Benign Strictures", a Class II medical device regulated under 21 CFR 876.5011. Submissions are reviewed by the Gastroenterology, Urology panel. Devices under this code are implants. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- PNB
- Device Class
- Class II
- Regulation Number
- 876.5011
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- Yes
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN150040 | boston scientific | WallFlex Biliary RX Fully Covered Stent System RMV | June 3, 2016 |