Clearance Summary
REZA BAND(TM) UPPER ESOPHAGEAL (UES) SPHINCTER ASSIST DEVICE received FDA 510(k) clearance under submission number DEN130046, sponsored by Somna Therapeutics, LLC. The device was reviewed via the Direct premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 2015-03-06.
- Submission: DEN130046
- Applicant / Sponsor: Somna Therapeutics, LLC
- Clearance pathway: Direct
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.5900
- Decision date: 2015-03-06
Classification & Regulation
This clearance is catalogued under FDA product code PKA and 21 CFR 874.5900, within the Ear, Nose, Throat review panel as a Class II device.