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# BrightWater Medical 510(k) for ConvertX Biliary Stent
- URL: https://www.fdaweb.com/brightwater-medical-510-k-for-convertx-biliary-stent/
- Published: 2019-03-25T12:00:00.000Z
- Updated: 2026-09-15T01:15:22.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5143690

FDA has cleared a BrightWater Medical 510(k) for the ConvertX Biliary Stent System for treating biliary obstructions. The company describes the device as the first system to provide interventional radiologists with a percutaneous plastic biliary stent option. It is designed to eliminate the need for a second invasive procedure. “Rather than a drain-to-stent exchange, the ConvertX System itself enables stent release in less than one minute during an in-office visit or at bedside without the need for sedation or repeated drain insertions,” BrightWater says.