ClearUP Sinus Pain Relief
K-Number: K182025 · 2019-01-02
ApplicantTivic Health Systems, Inc.
Decision Date2019-01-02
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
ClearUP Sinus Pain Relief is a medical device manufactured by Tivic Health Systems, Inc.. It received FDA 510(k) clearance on 2019-01-02 under approval number K182025. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ClearUP Sinus Pain Relief?
ClearUP Sinus Pain Relief is a medical device that received FDA 510(k) clearance on 2019-01-02. It is manufactured by Tivic Health Systems, Inc.. The 510(k) number is K182025.
When was ClearUP Sinus Pain Relief approved by the FDA?
ClearUP Sinus Pain Relief received FDA 510(k) clearance on 2019-01-02, under approval number K182025.
What company makes ClearUP Sinus Pain Relief?
ClearUP Sinus Pain Relief is manufactured by Tivic Health Systems, Inc..
What is the FDA product code for ClearUP Sinus Pain Relief?
The FDA product code for ClearUP Sinus Pain Relief is GZJ.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.