PKA — External Upper Esophageal Sphincter (Ues) Compression Device Class II
FDA product code PKA covers "External Upper Esophageal Sphincter (Ues) Compression Device", a Class II medical device regulated under 21 CFR 874.5900. Submissions are reviewed by the Ear, Nose, Throat panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PKA
- Device Class
- Class II
- Regulation Number
- 874.5900
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Ear, Nose, Throat
- Implant
- No
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.