Product code QNU— Ear, Nose, Throat

ClearUP Sinus Relief

Classification name: Transcutaneous Electrical Nerve Stimulator For The Relief Of Congestion
Device class: Class 2
Regulation: 21 CFR 874.6000
Advisory panel: Ear, Nose, Throat
Total cleared: 1
First cleared: 2021-03-05
Most recent: 2021-03-05

FDA classification definition

“A transcutaneous electrical nerve stimulator for the relief of congestion is a device that electrically stimulates the skin overlying the paranasal sinuses to relieve congestion.”
— U.S. Food and Drug Administration, device classification record for product code QNU under 21 CFR 874.6000, via openFDA

Market context for product code QNU

FDA has cleared 1 device under product code QNU, all in 2021, 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.

Top applicants under product code QNU

Tivic Health Systems, Inc.1 clearance

Recent clearances under product code QNU

DEN200006 — ClearUP Sinus ReliefTivic Health Systems, Inc.·2021-03-05

Data sourced from openFDA. This site is unofficial and independent of the FDA.