510(k) DEN200006
DEN200006 is an FDA 510(k) premarket notification submitted by Tivic Health Systems, Inc. for the device "ClearUP Sinus Relief". The FDA issued a decision of De Novo Granted on March 5, 2021. The device falls under product code QNU (Transcutaneous Electrical Nerve Stimulator For The Relief Of Congestion), a Class II device regulated under 21 CFR 874.6000. Tivic Health Systems, Inc. has at least 1 other 510(k) clearance on record.
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.