FDA 510(k)

Single Use Cytology Brush V (BC-V600P-3010)

Número K: K250993 · 2025-12-18

RequerenteOlympus Medical Systems Corporation

Data da decisão2025-12-18

Código do produtoFDX

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Single Use Cytology Brush V (BC-V600P-3010) is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Medical Systems Corporation. It received FDA 510(k) clearance on 2025-12-18 under 510(k) number K250993. The device is classified under product code FDX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Single Use Cytology Brush V (BC-V600P-3010)?

Single Use Cytology Brush V (BC-V600P-3010) is a medical device that received FDA 510(k) clearance on 2025-12-18. The listed applicant is Olympus Medical Systems Corporation. The 510(k) number is K250993.

When did Single Use Cytology Brush V (BC-V600P-3010) receive FDA 510(k) clearance?

Single Use Cytology Brush V (BC-V600P-3010) received FDA 510(k) clearance on 2025-12-18, under 510(k) number K250993.

Who is the listed applicant for Single Use Cytology Brush V (BC-V600P-3010)?

The FDA 510(k) record lists Olympus Medical Systems Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Single Use Cytology Brush V (BC-V600P-3010)?

The FDA product code for Single Use Cytology Brush V (BC-V600P-3010) is FDX.

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Fonte oficial

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