510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN200006Unknown

ClearUP Sinus Relief

Tivic Health Systems, Inc., Menlo Park CA / Direct, Unknown
FDA source (opens on fda.gov)

DEN200006 is the FDA 510(k) clearance record for ClearUP Sinus Relief, a class II device, cleared for Tivic Health Systems, Inc. on under FDA product code QNU (Transcutaneous Electrical Nerve Stimulator For The Relief Of Congestion). FDA's definition for product code QNU reads: "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". FDA records list 2 510(k) clearances for Tivic Health Systems, Inc., from to . As of , FDA records show no recalls naming DEN200006.

Clearance record

Decision date
Received
(392 days to decision)
Product code
QNU Transcutaneous Electrical Nerve Stimulator For The Relief Of Congestion
Regulation
21 CFR 874.6000
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Tivic Health Systems, Inc. 750 Menlo Ave., Menlo Park CA
Third party review
No

Clearances, product code QNU

Trailing 12 months

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

FDA records show no clearances under product code QNU in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QNU, 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