FDA product code PNB: Biliary Stent System For Benign Strictures
PNB is the FDA product code for biliary stent system for benign strictures. It is a Class II device, regulated under 21 CFR 876.5011 and reviewed by the Gastroenterology and Urology panel. Devices under PNB reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Biliary Stent System For Benign Strictures |
| Device class | Class II |
| Regulation | 21 CFR 876.5011 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Implant | Yes |
Recalls for PNB devices
openFDA lists no recalls for product code PNB.
Frequently asked questions
What is FDA product code PNB?
PNB is the FDA product code for biliary stent system for benign strictures. It is a Class II device, regulated under 21 CFR 876.5011 and reviewed by the Gastroenterology and Urology panel.
What device class is PNB?
Class II, regulation 21 CFR 876.5011. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code PNB
- Run a recall and safety report across every PNB manufacturer
- Watch product code PNB for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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