Product code PKA— Ear, Nose, Throat
REZA BAND(TM) UPPER ESOPHAGEAL (UES) SPHINCTER ASSIST DEVICE
- Classification name
- External Upper Esophageal Sphincter (Ues) Compression Device
- Device class
- Class 2
- Regulation
- 21 CFR 874.5900
- Advisory panel
- Ear, Nose, Throat
- Total cleared
- 2
- First cleared
- Most recent
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.”
Market context for product code PKA
FDA has cleared devices under product code PKA between 2015 and 2018, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2018
- 2015
Top applicants under product code PKA
Recent clearances under product code PKA
Data sourced from openFDA. This site is unofficial and independent of the FDA.