ClearUP Sinus Pain Relief— 510(k) K182025

Name: FDA 510(k) clearance K182025
Creator: U.S. Food and Drug Administration
Published: 2019-01-02

Substantially Equivalent

Tivic Health Systems, Inc.

FDA 510(k) clearance K182025 for ClearUP Sinus Pain Relief, Substantially Equivalent on 2019-01-02. Applicant: Tivic Health Systems, Inc.. Device class: 2.

Clearance details

Applicant: Tivic Health Systems, Inc.
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2018-07-30
Decision date: 2019-01-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Menlo Park, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GZJ

view all

K252712 — STIMPOD NMS460 Nerve Stimulator2026-05-28
K252767 — actiTENS mini2026-01-16
K252236 — CP Relief Wand Rx - TENS/NMES2025-08-15
K232441 — Unipro (K-UNIPRO-US)2024-08-30
K241228 — TENSWave2024-08-27

More clearances from Tivic Health Systems, Inc.

view all

DEN200006 — ClearUP Sinus Relief2021-03-05

Data sourced from openFDA. This site is unofficial and independent of the FDA.