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FDA 510(k)

Tesera-k SC System

K-Number: K242928 · 2025-04-10

ApplicantKyocera Medical Technologies, Inc.
Decision Date2025-04-10
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 2025-04-10 under approval number K242928. 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 2025-04-10. It is manufactured by Kyocera Medical Technologies, Inc.. The 510(k) number is K242928.

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

Tesera-k SC System received FDA 510(k) clearance on 2025-04-10, under approval number K242928.

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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