# K010714: Expander, Models 1400880, 1401280, 1401680, 1401880, 1410420, 1410620, 1410830

- Pathway: 510(k) (Traditional)
- Applicant: Medi-Globe Corp.
- Decided: Jan 21, 2003 after 683 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: 2 generations back to K851647 (1985). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974788: Cre (TM) Balloon Dilatation Catheter, Boston Scientific Corp (1998) Summary page 1.
- K973113: Modified Olbert Balloon Catheter System, Noprofile Olbert Balloon Catheter System, Boston Scientific Corp (1997) Summary page 1.

## Indications for use
The Medi-Globe Balloon Dilatation Catheters are intended to be used for Endoscopic Dilation of Biliary Tract, Esophageal or Shincter Stenosis.

Source page: https://510kreport.com/device/K010714
Methodology: https://510kreport.com/methodology