FDA 510(k)

TS-RF Generator (STS10)

Número K: K251566 · 2025-11-17

Data da decisão2025-11-17

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

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

Perguntas frequentes

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. The listed applicant is Starmed Co., Ltd.. The 510(k) number is K251566.

When did TS-RF Generator (STS10) receive FDA 510(k) clearance?

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

Who is the listed applicant for TS-RF Generator (STS10)?

The FDA 510(k) record lists Starmed Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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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Fonte oficial

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