FDA 510(k)

TS-RF Generator (STS10)

K-Number: K251566 · 2025-11-17

Decision Date2025-11-17

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

TS-RF Generator (STS10) is a medical device manufactured by Starmed Co., Ltd.. It received FDA 510(k) clearance on 2025-11-17 under approval number K251566. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TS-RF Generator (STS10)?

TS-RF Generator (STS10) is a medical device that received FDA 510(k) clearance on 2025-11-17. It is manufactured by Starmed Co., Ltd.. The 510(k) number is K251566.

When was TS-RF Generator (STS10) approved by the FDA?

TS-RF Generator (STS10) received FDA 510(k) clearance on 2025-11-17, under approval number K251566.

What company makes TS-RF Generator (STS10)?

TS-RF Generator (STS10) is manufactured by Starmed Co., Ltd..

What is the FDA product code for TS-RF Generator (STS10)?

The FDA product code for TS-RF Generator (STS10) is GEI.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.