PNBClass II
Biliary Stent System For Benign Strictures
21 CFR 876.5011 / Gastroenterology, Urology
PNB is the FDA product code for Biliary Stent System For Benign Strictures, a class II device type, regulated under 21 CFR 876.5011. FDA's definition for this code reads: "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...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- PNB
- Device name
- Biliary Stent System For Benign Strictures
- FDA 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.
- Regulation
- 21 CFR 876.5011
- Device class
- Class II
- Review panel
- Gastroenterology, Urology
- Submission type
- 510(k)
- Implant
- Yes
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code PNB
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2016 | 1 |
Applicants with the most clearances
Product code PNB| Applicant | Clearances |
|---|---|
| Boston Scientific Corporation | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.