A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed pancreatic duct (e.g., due to stricture or malignancy) to maintain luminal patency; it may also be intended to treat a wide variety of conditions in pancreatic endoscopy (e.g.
| Company | Devices | Share |
|---|---|---|
| Cook Ireland Ltd | 311 | 59% |
| Boston Scientific Corporation | 163 | 31% |
| Hobbs Medical, Inc. | 35 | 7% |
| Olympus Medical Systems Corp. | 20 | 4% |
Company = labeler of record on GUDID. 4 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 | 490 |
| FGE | Catheter, Biliary, Diagnostic | 70 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 10 |
Use these as the dimensions to specify in a tender line.
529 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Polymeric pancreatic stent, non-bioabsorbable", from 4 companies. The largest labeler is Cook Ireland Ltd with 59% of records.
FGE (CATHETER, BILIARY, DIAGNOSTIC), FGE (Catheter, Biliary, Diagnostic), FGE (Stents, Drains And Dilators For The Biliary Ducts)
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.