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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 K261274
Device Name EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip ProCore® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes
Applicant
Cook Ireland, Ltd.
O'Halloran Rd.
National Technology Park, Plassey
Limerick,  IE V94 N8X2
Applicant Contact Caoimhe Murphy
Correspondent
Cook Ireland, Ltd.
O'Halloran Rd.
National Technology Park, Plassey
Limerick,  IE V94 N8X2
Correspondent Contact Caoimhe Murphy
Regulation Number876.1075
Classification Product Code
FCG  
Date Received04/17/2026
Decision Date 07/24/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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