FDA 510(k)

Hubly Drill (H100)

Número K: K250815 · 2025-11-06

Data da decisão2025-11-06

Código do produtoHBE

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Hubly Drill (H100) is the device name listed in this FDA 510(k) record. The listed applicant is Hubly, Inc.. It received FDA 510(k) clearance on 2025-11-06 under 510(k) number K250815. The device is classified under product code HBE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Hubly Drill (H100)?

Hubly Drill (H100) is a medical device that received FDA 510(k) clearance on 2025-11-06. The listed applicant is Hubly, Inc.. The 510(k) number is K250815.

When did Hubly Drill (H100) receive FDA 510(k) clearance?

Hubly Drill (H100) received FDA 510(k) clearance on 2025-11-06, under 510(k) number K250815.

Who is the listed applicant for Hubly Drill (H100)?

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

What is the FDA product code for Hubly Drill (H100)?

The FDA product code for Hubly Drill (H100) is HBE.

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

K230619Hubly Electric Drill (H100)

Dispositivos Relacionados (Código: HBE)

Fonte oficial

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