510(k) DEN130046
DEN130046 is an FDA 510(k) premarket notification submitted by Somna Therapeutics, LLC for the device "REZA BAND(TM) UPPER ESOPHAGEAL (UES) SPHINCTER ASSIST DEVICE". The FDA issued a decision of De Novo Granted on March 6, 2015. The device falls under product code PKA (External Upper Esophageal Sphincter (Ues) Compression Device), a Class II device regulated under 21 CFR 874.5900. Somna Therapeutics, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- March 6, 2015
- Date Received
- November 14, 2013
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- External Upper Esophageal Sphincter (Ues) Compression Device
- Device Class
- Class II
- Regulation Number
- 874.5900
- Review Panel
- EN
- Submission Type
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.