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510(k) Data Aggregation

K Number

Device Name

EchoTip AcuCore EUS Biopsy Needle (ECHO-BX-19)

Manufacturer

Cook Ireland Ltd.

Date Cleared

2024-07-29

(90 days)

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Regulation Number

Type

Panel

Gastroenterology/Urology

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N/A

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Device Name :

EchoTip AcuCore EUS Biopsy Needle (ECHO-BX-19)

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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