DEN200006 is an FDA 510(k) submission for the ClearUP Sinus Relief. This device is classified as a Transcutaneous Electrical Nerve Stimulator For The Relief Of Congestion (Class II - Special Controls, product code QNU).
Submitted by Tivic Health Systems, Inc. (Menlo Park, US). The FDA issued a Not Cleared (DENG) decision on March 5, 2021.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.6000. 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..
| 510(k) Number | DEN200006 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | February 07, 2020 |
| Decision Date | March 05, 2021 |
| Days to Decision | 392 days |
| Submission Type | Direct |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | - |
| Product Code | QNU - Transcutaneous Electrical Nerve Stimulator For The Relief Of Congestion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.6000 |
| 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. |