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FDA 510(k)

Tesera-K SC System

K-Number: K223105 · 2022-12-22

ApplicantKyocera Medical Technologies, Inc.
Decision Date2022-12-22
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Tesera-K SC System is a medical device manufactured by Kyocera Medical Technologies, Inc.. It received FDA 510(k) clearance on 2022-12-22 under approval number K223105. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tesera-K SC System?

Tesera-K SC System is a medical device that received FDA 510(k) clearance on 2022-12-22. It is manufactured by Kyocera Medical Technologies, Inc.. The 510(k) number is K223105.

When was Tesera-K SC System approved by the FDA?

Tesera-K SC System received FDA 510(k) clearance on 2022-12-22, under approval number K223105.

What company makes Tesera-K SC System?

Tesera-K SC System is manufactured by Kyocera Medical Technologies, Inc..

What is the FDA product code for Tesera-K SC System?

The FDA product code for Tesera-K SC System is OVE.

Other Devices by Kyocera Medical Technologies, Inc.

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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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