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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 K210476
Device Name EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle, EchoTip Ultra Endobronchial High Definition Ultrasound Needle, EchoTip ProCore Endobronchial High Definition Ultrasound Biopsy Needle
Applicant
Cook Ireland, Ltd.
O' Halloran Rd.
National Technology Park
Limerick,  IE V94 N8X2
Applicant Contact Fay Dalton
Correspondent
Cook Ireland, Ltd.
O' Halloran Rd.
National Technology Park
Limerick,  IE V94 N8X2
Correspondent Contact Jane Kennedy
Regulation Number876.1075
Classification Product Code
FCG  
Date Received02/19/2021
Decision Date 05/20/2021
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
Recalls CDRH Recalls
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