# K251658: Endoflux™ Biliary & Pancreatic Stent Sets

- Pathway: 510(k) (Traditional)
- Applicant: Medi-Globe GmbH
- Decided: Apr 16, 2026 after 321 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K851962 (1985). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172044: Cotton-Huibregtse Stent, Cotton-Leung Biliary Stent, Cotton-Leung Sof-Flex Biliary Stent, Soehendra Tannenbaum Biliary Stent, Zimmon Biliary Stent, Guiding Catheter, Pushing catheter, Fusion pushing catheter, Stent Introducer Set, Fusion Oasis One Action Sent Introduction System, Zimmon Biliary Stent Set, Oasis One Action Stent Introduction System, Solus Double Pigtail Stent and Introduction System, Cotton-Huibregtse Biliary Stent Set, Cotton-Leung Biliary Stent Set, Oasis One Action S, Cook Ireland, Ltd. (2018) Summary page 5.
- K172057: Zimmon Pancreatic Stents/Stent sets, Geenen Pancreatic Stents/Stent Sets, Pushing Catheter and Guiding Catheter, Johlin Pancreatic Wedge Stent and Introducer Set, Cook Ireland, Ltd. (2018) Summary page 5.

## Indications for use
Biliary Stents/Stent sets are used to drain obstructed biliary ducts Pancreatic Stents/Stent sets are used to drain obstructed pancreatic ducts Guiding Catheters, Pushers, and Stent Introducer Sets are used for endoscopic biliary and pancreatic stent placement

Source page: https://510kreport.com/device/K251658
Methodology: https://510kreport.com/methodology