Search Results
Found 1 results
510(k) Data Aggregation
K Number
K103437Device Name
US ENDOSCOPY CYTOLOGY BRUSHManufacturer
Date Cleared
2010-12-23
(30 days)
Product Code
Regulation Number
876.1500Type
SpecialReference & Predicate Devices
N/A
Why did this record match?
Device Name :
US ENDOSCOPY CYTOLOGY BRUSH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
The disposable Cytology Brush is intended to retrieve cytological cell samples in the gastrointestinal tract
Device Description
Cytology Brush
AI/ML Overview
The provided document is a 510(k) clearance letter from the FDA for a device called "US Endoscopy Cytology Brush." It does not contain any information about acceptance criteria, device performance, study designs, sample sizes, expert qualifications, or ground truth methodologies as requested in the prompt.
This document is a regulatory approval notice, not a study report. Therefore, I cannot extract the requested information from the given text.
Ask a Question
Ask a specific question about this device
Page 1 of 1