GIE Medical · Class II · Cleared Mar 13, 2026
| K-number | K253987 |
| Device name | BARE Wireguided Balloon Dilation Catheter (1235) |
| Applicant | GIE Medical |
| Product code | FGE |
| Device class | Class II |
| Decision date | Mar 13, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 876.5010 |
The BARE Wireguided Balloon Dilation Catheter is a dual-lumen, over-the-wire balloon catheter designed for endoscopic dilation of strictures in the alimentary tract and the Sphincter of Oddi in adult and adolescent patients. It features a three-stage semicompliant balloon with radiopaque marker bands for positioning under fluoroscopy and is compatible with 0.035-inch guidewires.
The device is similar to the predicate in design, materials, and operation as a single-use dual-lumen catheter with a 3-stage balloon delivered through an endoscope. While minor design differences exist, bench testing demonstrated substantial equivalence in crossing profile, balloon compliance, tensile strength, kink resistance, and compatibility with guidewires and endoscopes.
ISO 11135:2014 (sterilization validation), ISO 10993-1:2018 (biocompatibility testing), and mechanical testing for dimensional specifications, balloon compliance curves, burst pressure, balloon fatigue, inflate/deflate time, marker band location, luer hub leakage, tensile strength, kink resistance, and device compatibility.
The subject device and predicate device (CRE Wireguided Balloon Dilatation Catheter, K112994) have identical indications for use and similar design, materials, and operational principles. Non-clinical testing demonstrated that design input requirements were met and the device performs as safely, effectively, and as well as the legally marketed predicate device.
View the full FDA submission: accessdata.fda.gov