# K253987: BARE Wireguided Balloon Dilation Catheter (1235)

- Pathway: 510(k) (Traditional)
- Applicant: GIE Medical
- Decided: Mar 13, 2026 after 91 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 K974788 (1998). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112994: Cre Ditatation Ballon, Boston Scientific Corporation (2012) Summary page 5.

## Indications for use
The BARE Wireguided Balloon Dilation Catheter is indicated for use in adult and adolescent populations to endoscopically dilate strictures of the alimentary tract. Also indicated in adults for endoscopic dilation of the Sphincter of Oddi with or without prior sphincterotomy.

Source page: https://510kreport.com/device/K253987
Methodology: https://510kreport.com/methodology