FDA 510(k)

ClearUP Sinus Pain Relief

K-Number: K182025 · 2019-01-02

Decision Date2019-01-02

Product CodeGZJ

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

ClearUP Sinus Pain Relief is the device name listed in this FDA 510(k) record. The listed applicant is Tivic Health Systems, Inc.. It received FDA 510(k) clearance on 2019-01-02 under 510(k) 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. The listed applicant is Tivic Health Systems, Inc.. The 510(k) number is K182025.

When did ClearUP Sinus Pain Relief receive FDA 510(k) clearance?

ClearUP Sinus Pain Relief received FDA 510(k) clearance on 2019-01-02, under 510(k) number K182025.

Who is the listed applicant for ClearUP Sinus Pain Relief?

The FDA 510(k) record lists Tivic Health Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ClearUP Sinus Pain Relief?

The FDA product code for ClearUP Sinus Pain Relief is GZJ.

Related Devices (Code: GZJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252712STIMPOD NMS460 Nerve StimulatorAlgiamed Technologies USA, Inc.K252767actiTENS miniSublimed K252236CP Relief Wand Rx - TENS/NMESN & C Holdings, LLC K232441Unipro (K-UNIPRO-US)Tenscare, Ltd.K241228TENSWaveZynex Medical Officer K233046Electrical Neuromuscular Stimulator, Cure TrioOriental Inspiration Limited

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.