FDA 510(k)

Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)

Número K: K262792 · 2026-08-12

Data da decisão2026-08-12

Código do produtoKNW

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09) is the device name listed in this FDA 510(k) record. The listed applicant is Hologic, Inc.. It received FDA 510(k) clearance on 2026-08-12 under 510(k) number K262792. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)?

Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09) is a medical device that received FDA 510(k) clearance on 2026-08-12. The listed applicant is Hologic, Inc.. The 510(k) number is K262792.

When did Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09) receive FDA 510(k) clearance?

Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09) received FDA 510(k) clearance on 2026-08-12, under 510(k) number K262792.

Who is the listed applicant for Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)?

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

What is the FDA product code for Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)?

The FDA product code for Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09) is KNW.

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Fonte oficial

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