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FDA 510(k)

Tympanostomy Tubes

K-Number: K232059 · 2023-11-24

Decision Date2023-11-24
Product CodeETD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Tympanostomy Tubes is a medical device manufactured by Grace Medical, Inc.. It received FDA 510(k) clearance on 2023-11-24 under approval number K232059. The device is classified under product code ETD. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tympanostomy Tubes?

Tympanostomy Tubes is a medical device that received FDA 510(k) clearance on 2023-11-24. It is manufactured by Grace Medical, Inc.. The 510(k) number is K232059.

When was Tympanostomy Tubes approved by the FDA?

Tympanostomy Tubes received FDA 510(k) clearance on 2023-11-24, under approval number K232059.

What company makes Tympanostomy Tubes?

Tympanostomy Tubes is manufactured by Grace Medical, Inc..

What is the FDA product code for Tympanostomy Tubes?

The FDA product code for Tympanostomy Tubes is ETD.

Related Clinical Trials

Other Devices by Grace Medical, Inc.

Related Devices (Code: ETD)

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.