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FDA 510(k), K160229, Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle
FDA 510(k), K160229, Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle
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$149.00 USD
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$149.00 USD
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510(K) Number: K160229
Device Name: Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle
Manufacturer: Lynsey Shine
Device Classification Name: Biopsy Needle
Regulation Number: FCG
Classification Product Code: 02/01/2016
Date Received: 03/21/2016
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle
Manufacturer: Lynsey Shine
Device Classification Name: Biopsy Needle
Regulation Number: FCG
Classification Product Code: 02/01/2016
Date Received: 03/21/2016
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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