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FDA 510(k)

Instrument Case

K-Number: K231604 · 2023-08-24

ApplicantCochlear Americas
Decision Date2023-08-24
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Instrument Case is a medical device manufactured by Cochlear Americas. It received FDA 510(k) clearance on 2023-08-24 under approval number K231604. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Instrument Case?

Instrument Case is a medical device that received FDA 510(k) clearance on 2023-08-24. It is manufactured by Cochlear Americas. The 510(k) number is K231604.

When was Instrument Case approved by the FDA?

Instrument Case received FDA 510(k) clearance on 2023-08-24, under approval number K231604.

What company makes Instrument Case?

Instrument Case is manufactured by Cochlear Americas.

What is the FDA product code for Instrument Case?

The FDA product code for Instrument Case is KCT.

Other Devices by Cochlear Americas

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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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