> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Clears SoundBite Crossing System
- URL: https://www.fdaweb.com/fda-clears-soundbite-crossing-system/
- Published: 2021-04-22T12:00:00.000Z
- Updated: 2026-09-14T16:55:56.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5149169

FDA has cleared a Soundbite 510(k) for the SoundBite Crossing System — Peripheral with an 0.014” Active Wire. The company says the recanalization tool is designed to help physicians’ placement of conventional guidewires or treatment devices in the intraluminal space beyond chronic total occlusions in patients suffering from heavily calcified above-the-knee and below-the-knee peripheral artery disease. It uses Soundbite’s proprietary method to produce and deliver shock waves via guidewire platforms to selectively “micro- jackhammer” through calcified lesions, it says.