510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN130046Unknown

Reza Band(tm) Upper Esophageal (Ues) Sphincter Assist Device

Somna Therapeutics, LLC, Germantown WI / Direct, Unknown
FDA source (opens on fda.gov)

DEN130046 is the FDA 510(k) clearance record for REZA BAND(TM) UPPER ESOPHAGEAL (UES) SPHINCTER ASSIST DEVICE, a class II device, cleared for Somna Therapeutics, LLC on under FDA product code PKA (External Upper Esophageal Sphincter (Ues) Compression Device). FDA's definition for product code PKA reads: "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". FDA records list 2 510(k) clearances for Somna Therapeutics, LLC, from to . As of , FDA records show no recalls naming DEN130046.

Clearance record

Decision date
Received
(477 days to decision)
Product code
PKA External Upper Esophageal Sphincter (Ues) Compression Device
Regulation
21 CFR 874.5900
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Somna Therapeutics, LLC W175 N11081 Stonewood Dr., Germantown WI
Third party review
No

Clearances, product code PKA

Trailing 12 months

FDA records hold no clearances under product code PKA in the trailing twelve months.

FDA records show no clearances under product code PKA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PKA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260