FDA 510(k)

AlphaTriPart - Monopolar MIC Instruments

Número K: K261179 · 2026-07-22

Data da decisão2026-07-22

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

AlphaTriPart - Monopolar MIC Instruments is the device name listed in this FDA 510(k) record. The listed applicant is Gimmi GmbH. It received FDA 510(k) clearance on 2026-07-22 under 510(k) number K261179. 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 AlphaTriPart - Monopolar MIC Instruments?

AlphaTriPart - Monopolar MIC Instruments is a medical device that received FDA 510(k) clearance on 2026-07-22. The listed applicant is Gimmi GmbH. The 510(k) number is K261179.

When did AlphaTriPart - Monopolar MIC Instruments receive FDA 510(k) clearance?

AlphaTriPart - Monopolar MIC Instruments received FDA 510(k) clearance on 2026-07-22, under 510(k) number K261179.

Who is the listed applicant for AlphaTriPart - Monopolar MIC Instruments?

The FDA 510(k) record lists Gimmi GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AlphaTriPart - Monopolar MIC Instruments?

The FDA product code for AlphaTriPart - Monopolar MIC Instruments is GEI.

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