A non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. It is a mesh structure made of metal which is covered/lined with a synthetic polymer material (e.g., silicone) that
| Company | Devices | Share |
|---|---|---|
| Boston Scientific Corporation | 48 | 53% |
| W. L. Gore & Associates, Inc. | 42 | 47% |
Company = labeler of record on GUDID. 2 companies in total; top 12 shown. Click headers to sort.
Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.
| Code | Name | Devices |
|---|---|---|
| FGE | Catheter, Biliary, Diagnostic | 42 |
| FGE | CATHETER, BILIARY, DIAGNOSTIC | 32 |
| FGE | Stents, drains and dilators for the biliary ducts | 11 |
| PNB | Biliary stent system for benign strictures | 5 |
Use these as the dimensions to specify in a tender line.
90 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Polymer-metal biliary stent, non-bioabsorbable", from 2 companies. The largest labeler is Boston Scientific Corporation with 53% of records.
FGE (Catheter, Biliary, Diagnostic), FGE (CATHETER, BILIARY, DIAGNOSTIC), FGE (Stents, drains and dilators for the biliary ducts), PNB (Biliary stent system for benign strictures)
No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.
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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.