FDA product code · Gastroenterology and urology
Biliary Stent System For Benign Strictures
1 FDA decision since 2016. No recall names this code. The most-cited predicate is DEN150040, named by 1 later device.
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.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of PNB at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.
FDA decisions per year · PNB
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · PNB
Too few PNB 510(k)s in any year since 2007 to give a median.
Recalls per year · PNB
No recall names PNB since 2007.
Adverse event reports per year · PNB
36in 2025
MAUDE reports naming product code PNB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 22 |
| 2018 | 0 | — | 0 | 48 |
| 2019 | 0 | — | 0 | 46 |
| 2020 | 0 | — | 0 | 48 |
| 2021 | 0 | — | 0 | 29 |
| 2022 | 0 | — | 0 | 16 |
| 2023 | 0 | — | 0 | 27 |
| 2024 | 0 | — | 0 | 39 |
| 2025 | 0 | — | 0 | 36 |
| 2026 | 0 | — | 0 | — |
Planning a device in PNB? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report