FDAnews Device Daily Bulletin
Medical Devices / Submissions and Approvals

Flat Medical’s Epidural Protector Cleared by FDA

May 20, 2019
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The FDA granted Flat Medical with 510(k) clearance for its EpiFaith syringe, a device used for delivering safe epidural injections.

The indicating syringe is a physician-oriented safeguard for epidural analgesia during labor, chronic pain management and surgical anesthesia.

The device alerts anesthesiologists to the moment it has arrived at the epidural space, avoiding the risk of paralysis, prolonged admission times and associated costs.

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