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FDA PMA

Tympanostomy tube delivery product with drug

PMA Number: P190016 · 2026-07-31

ApplicantTusker Medical, Inc.
Decision Date2026-07-31
PMA NumberP190016
Product CodeQJA
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeEN

Device Summary

Tympanostomy tube delivery product with drug is the device name listed in this FDA 510(k) record. The listed applicant is Tusker Medical, Inc.. It received FDA 510(k) clearance on 2026-07-31. The device is classified under product code QJA. It was reviewed by the EN advisory panel.

Frequently Asked Questions

What is the Tympanostomy tube delivery product with drug?

Tympanostomy tube delivery product with drug is a medical device that received FDA 510(k) clearance on 2026-07-31. The listed applicant is Tusker Medical, Inc..

When did Tympanostomy tube delivery product with drug receive FDA 510(k) clearance?

The clearance date for Tympanostomy tube delivery product with drug can be found in the official FDA records.

Who is the listed applicant for Tympanostomy tube delivery product with drug?

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

What is the FDA product code for Tympanostomy tube delivery product with drug?

The FDA product code for Tympanostomy tube delivery product with drug is QJA.

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.

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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.

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