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External Upper Esophageal Sphincter (Ues) Compression Device

FDA product code PKA · 1 cleared devices

Class 2 Ear, Nose, Throat
Regulation
21 CFR 874.5900
Review panel
EN
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2018-04-13 – 2018-04-13

The external UES compression device is intended to reduce the symptoms of laryngopharyngeal reflux (LPR) disease by reducing the regurgitation of stomach contents from passing through the upper esophageal sphincter.

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