FDA 510(k)

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

N.º K: K250993 · 2025-12-18

SolicitanteOlympus Medical Systems Corporation

Fecha de decisión2025-12-18

Código de productoFDX

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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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Otros registros que enlistan a Olympus Medical Systems Corporation como solicitante

K260824Gastrointestinal Videoscope Olympus GIF-2T1500 K260856Disposable Distal Attachment D-201-13404 K260401EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F (BF-UCP190F)K261183EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)K261260HD Camera Head OLYMPUS CH-S200-08-LB K252050Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D

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Dispositivos relacionados (Código: FDX)

K220063Single Use Cytology BrushZhejiang Chuangxiang Medical Technology Co., Ltd.K192908Fusion Cytology Brush, CytoMax II Double Lumen Cytology BrushesWilson-Cook Medical, Inc.K191485Deflectable Brush Biopsy SetCook Incorporated K182231Brush Biopsy Set ; Deflectable Brush Biopsy SetCook Incorporated K181317Fusion Cytology Brush, CytoMax II Double Lumen Cytology BrushWilson-Cook Medical, Inc.K172663Cytology BrushMicro-Tech (Nanjing) Co., Ltd.

Fuente oficial

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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.