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FDA 510(k)

Chemo Mouthpiece

K-Number: K232917 · 2024-01-23

ApplicantChemo Mouthpiece, LLC
Decision Date2024-01-23
Product CodeQUA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Chemo Mouthpiece is the device name listed in this FDA 510(k) record. The listed applicant is Chemo Mouthpiece, LLC. It received FDA 510(k) clearance on 2024-01-23 under 510(k) number K232917. The device is classified under product code QUA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Chemo Mouthpiece?

Chemo Mouthpiece is a medical device that received FDA 510(k) clearance on 2024-01-23. The listed applicant is Chemo Mouthpiece, LLC. The 510(k) number is K232917.

When did Chemo Mouthpiece receive FDA 510(k) clearance?

Chemo Mouthpiece received FDA 510(k) clearance on 2024-01-23, under 510(k) number K232917.

Who is the listed applicant for Chemo Mouthpiece?

The FDA 510(k) record lists Chemo Mouthpiece, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Chemo Mouthpiece?

The FDA product code for Chemo Mouthpiece is QUA.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT04745156A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade GliomasNOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED

Related PubMed Literature

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.

PMID: 41757395An economic analysis of Chemo Mouthpiece® versus supportive care for the reduction of oral mucositis incidence in patients receiving chemotherapy.Journal of comparative effectiveness research ()

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.

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