External Upper Esophageal Sphincter (Ues) Compression Device

PKA · Class II — Moderate Risk (510(k) clearance required) · Ear, Nose, Throat · 21 CFR 874.5900

Classification

FDA Product Code: PKA
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 874.5900
Review panel: EN
Medical specialty: Ear, Nose, Throat
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 2
Registered establishments: 1

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown