FDA 510(k)

HOTWIRE™ System RF Generator and Footswitch (optional accessory)

Número K: K252083 · 2025-08-12

Data da decisão2025-08-12

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

HOTWIRE™ System RF Generator and Footswitch (optional accessory) is the device name listed in this FDA 510(k) record. The listed applicant is Atraverse Medical, Inc.. It received FDA 510(k) clearance on 2025-08-12 under 510(k) number K252083. 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 HOTWIRE™ System RF Generator and Footswitch (optional accessory)?

HOTWIRE™ System RF Generator and Footswitch (optional accessory) is a medical device that received FDA 510(k) clearance on 2025-08-12. The listed applicant is Atraverse Medical, Inc.. The 510(k) number is K252083.

When did HOTWIRE™ System RF Generator and Footswitch (optional accessory) receive FDA 510(k) clearance?

HOTWIRE™ System RF Generator and Footswitch (optional accessory) received FDA 510(k) clearance on 2025-08-12, under 510(k) number K252083.

Who is the listed applicant for HOTWIRE™ System RF Generator and Footswitch (optional accessory)?

The FDA 510(k) record lists Atraverse Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HOTWIRE™ System RF Generator and Footswitch (optional accessory)?

The FDA product code for HOTWIRE™ System RF Generator and Footswitch (optional accessory) is GEI.

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Outros registros que listam Atraverse Medical, Inc. como candidato(a)

K252419HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)

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Fonte oficial

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