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FDA 510(k)

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

K-Number: K250993 · 2025-12-18

ApplicantOlympus Medical Systems Corporation
Decision Date2025-12-18
Product CodeFDX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Olympus Medical Systems Corporation. The 510(k) number is K250993.

When was Single Use Cytology Brush V (BC-V600P-3010) approved by the FDA?

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

What company makes Single Use Cytology Brush V (BC-V600P-3010)?

Single Use Cytology Brush V (BC-V600P-3010) is manufactured by Olympus Medical Systems Corporation.

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.

Related Clinical Trials

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Related Devices (Code: FDX)

K171573Fusion Cytology Brush, CytoMax II Double Lumen Cytology BrushWilson-Cook Medical, Inc. K171607Bronchi and Gastrointestinal Cytology BrushWilson-Cook Medical Inc./Cook Endoscopy K172663Cytology BrushMicro-Tech (Nanjing) 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

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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