meddevicedb.com FDA Device Reference

ClearUP Sinus Relief

DEN200006 Class II Direct
Decision Date
2021-03-05
Sponsor / Applicant
Tivic Health Systems, Inc.

Technical Specification

510(k) Submission ID DEN200006
Product Code QNU
Medical Specialty / Panel Ear, Nose, Throat
Regulation Citation 21 CFR 874.6000
Decision Date 2021-03-05
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

ClearUP Sinus Relief received FDA 510(k) clearance under submission number DEN200006, sponsored by Tivic Health Systems, Inc.. 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 2021-03-05.

Classification & Regulation

This clearance is catalogued under FDA product code QNU and 21 CFR 874.6000, within the Ear, Nose, Throat review panel as a Class II device.