PKA · Class II · 21 CFR 874.5900

FDA Product Code PKA: External Upper Esophageal Sphincter (ues) Compression Device

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.

Leading manufacturers include Somna Therapeutics, LLC.

2
Total
1
Cleared
293d
Avg days
2015
Since

FDA 510(k) Cleared External Upper Esophageal Sphincter (ues) Compression Device Devices (Product Code PKA)

2 devices
1–2 of 2
Cleared Apr 13, 2018
Reza Band, Reflux Band
K173934
Somna Therapeutics, LLC
Ear, Nose, Throat · 108d
Not Cleared Mar 06, 2015
REZA BAND(TM) UPPER ESOPHAGEAL (UES) SPHINCTER ASSIST DEVICE
DEN130046
Somna Therapeutics, LLC
Ear, Nose, Throat · 477d

About Product Code PKA - Regulatory Context