Last synced on 25 November 2022 at 11:04 pm

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

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K210476
510(k) Type
Traditional
Applicant
Cook Ireland Ltd.
Country
Ireland
FDA Decision
Substantially Equivalent
Decision Date
5/20/2021
Days to Decision
90 days
Submission Type
Summary

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

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K210476
510(k) Type
Traditional
Applicant
Cook Ireland Ltd.
Country
Ireland
FDA Decision
Substantially Equivalent
Decision Date
5/20/2021
Days to Decision
90 days
Submission Type
Summary