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510(k) K191485

Deflectable Brush Biopsy Set by Cook Incorporated — Product Code FDX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 26, 2019
Date Received
June 4, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Cytology Brush
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To collect cells for cytological evaluation.

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Other clearances for product code FDX

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  • K171607 — Bronchi and Gastrointestinal Cytology Brush (July 31, 2017)
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