K182025 is an FDA 510(k) clearance for the ClearUP Sinus Pain Relief. This device is classified as a Stimulator, Nerve, Transcutaneous, For Pain Relief (Class II - Special Controls, product code GZJ).
Submitted by Tivic Health Systems, Inc. (Menlo Park, US). The FDA issued a Cleared decision on January 2, 2019, 156 days after receiving the submission on July 30, 2018.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5890.
| 510(k) Number | K182025 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 30, 2018 |
| Decision Date | January 02, 2019 |
| Days to Decision | 156 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GZJ - Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5890 |