Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Bronchoscope Accessory
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 Number874.4680
Classification Product Code
KTI  
Date Received04/17/2026
Decision Date 07/24/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-