Brush Biopsy Set; Deflectable Brush Biopsy Set— 510(k) K182231

Name: FDA 510(k) clearance K182231
Creator: U.S. Food and Drug Administration
Published: 2019-05-01

Substantially Equivalent

Cook Incorporated

FDA 510(k) clearance K182231 for Brush Biopsy Set; Deflectable Brush Biopsy Set, Substantially Equivalent on 2019-05-01. Applicant: Cook Incorporated. Device class: 2.

Clearance details

Device name as filed: Brush Biopsy Set ; Deflectable Brush Biopsy Set
Applicant: Cook Incorporated
Product code: Code FDX
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2018-08-17
Decision date: 2019-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bloomington, IN, US

Download summary PDF View on FDA.gov ↗

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