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510(k) DEN200006

ClearUP Sinus Relief by Tivic Health Systems, Inc. — Product Code QNU

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
March 5, 2021
Date Received
February 7, 2020
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transcutaneous Electrical Nerve Stimulator For The Relief Of Congestion
Device Class
Class II
Regulation Number
874.6000
Review Panel
EN
Submission Type

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.

Other clearances by Tivic Health Systems, Inc.

  • K182025 — ClearUP Sinus Pain Relief (January 2, 2019)