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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Biopsy Needle
510(k) Number K241209
Device Name EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)
Applicant
Cook Ireland, Ltd.
O' Halloran Rd., National Technology Park, Plassey
Limerick,  IE V94 N8X2
Applicant Contact Brian O'Mara
Correspondent
Cook Ireland, Ltd.
O' Halloran Rd., National Technology Park, Plassey
Limerick,  IE V94 N8X2
Correspondent Contact Laura O'Reilly
Regulation Number876.1075
Classification Product Code
FCG  
Date Received04/30/2024
Decision Date 07/29/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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