# K241888: Single-use Balloon Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Leo Medical Co., Ltd.
- Decided: Dec 20, 2024 after 175 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: 4 generations back to K974788 (1998). 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)
- K112994: Cre Ditatation Ballon, Boston Scientific Corporation (2012) Summary page 6.
- K172520: CRE RX Biliary Balloon Dilatation Catheter, Boston Scientific Corporation (2017) Summary page 6.

## Indications for use
This device is indicated for use in adult and adolescent populations to endoscopically dilate strictures of the gastrointestinal tract. It is also indicated in adults for endoscopic dilatation of Sphincter of Oddi with or without prior sphincterotomy.

Source page: https://510kreport.com/device/K241888
Methodology: https://510kreport.com/methodology