510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PKAClass II

External Upper Esophageal Sphincter (Ues) Compression Device

21 CFR 874.5900 / Ear, Nose, Throat
FDA source (opens on fda.gov)

PKA is the FDA product code for External Upper Esophageal Sphincter (Ues) Compression Device, a class II device type, regulated under 21 CFR 874.5900. FDA's definition for this code reads: "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". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PKA
Device name
External Upper Esophageal Sphincter (Ues) Compression Device
FDA 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.
Regulation
21 CFR 874.5900
Device class
Class II
Review panel
Ear, Nose, Throat
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code PKA

By decision year
2 clearances under product code PKA with a decision year between 2015 and 2018, 2015 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PKA by decision year
YearClearances
20151
20181

Applicants with the most clearances

Product code PKA
Applicants holding the most 510(k) clearances under product code PKA
ApplicantClearances
Somna Therapeutics, LLC2

Companies listing this code with FDA

Companies whose registered establishments list this code