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

Biopsy Needle

Cook Ireland Ltd.

The following data is part of a premarket notification filed by Cook Ireland Ltd. with the FDA for 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.

Pre-market Notification Details

Device IDK210476
510k NumberK210476
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
ClassificationBiopsy Needle
Applicant Cook Ireland Ltd. O'Halloran Road, National Technology Park Limerick,  IE V94n8x2
ContactFay Dalton
CorrespondentJane Kennedy
Cook Ireland Ltd. O'Halloran Road, National Technology Park Limerick,  IE V94n8x2
Product CodeFCG  
CFR Regulation Number876.1075 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-19
Decision Date2021-05-20

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