PKA

External Upper Esophageal Sphincter (Ues) Compression Device

Product code

PKA

Device name

External Upper Esophageal Sphincter (Ues) Compression Device

Device class

Class 2

21 CFR

21 CFR 874.5900

Medical specialty

Ear, Nose, Throat

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

2 (all years; only the last 3 years are listed here)

FDA classification definition

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).