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FDA 510(k)

Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes

K-Number: K192908 · 2019-11-14

ApplicantWilson-Cook Medical, Inc.
Decision Date2019-11-14
Product CodeFDX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes is a medical device manufactured by Wilson-Cook Medical, Inc.. It received FDA 510(k) clearance on 2019-11-14 under approval number K192908. 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 Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes?

Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes is a medical device that received FDA 510(k) clearance on 2019-11-14. It is manufactured by Wilson-Cook Medical, Inc.. The 510(k) number is K192908.

When was Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes approved by the FDA?

Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes received FDA 510(k) clearance on 2019-11-14, under approval number K192908.

What company makes Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes?

Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes is manufactured by Wilson-Cook Medical, Inc..

What is the FDA product code for Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes?

The FDA product code for Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes is FDX.

Related Clinical Trials

NCT07614529 Hyperangulated vs Standard Videolaryngoscopy vs Direct Laryngoscopy for Double-Lumen Endobronchial Tube Intubation NOT_YET_RECRUITING NCT06375967 EUS-Gallbladder vs CDS as First Line in MBDO- Palliative (CARPEGIEM Trial) SUSPENDED NCT07212855 Use of Glycine Powder and an Angled Implant Brush in Oral Hygiene Procedures in Patients Rehabilitated With Columbus Bridge Protocol COMPLETED NCT07097584 Effect of Small Double-lumen Tube on the Intubation Time of Thoracoscopic Pulmonectomy in Asian Women COMPLETED NCT07537803 Comparison of The Effectiveness of Autobrush (U-shaped Toothbrush) Versus Manual Regular Toothbrush Among Children Aged From 9-12 Years COMPLETED

Other Devices by Wilson-Cook Medical, Inc.

K160170Lehman Manometry Catheter K161203Soehendra Stent Retriever K171573Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush K171548Cotton Graduated Dilation Catheter, Fusion Biliary Dilation Catheter, Soehendra Biliary Dilation Catheter, Geenen Graduated Dilation Catheter K170292Tri-Ex Extraction Balloon With Multiple Sizing K171596ECHO-3-22: Echotip Ultra and EUSN-1, EUSN-3: Echotip Ultrasound Needle

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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. 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.

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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