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FDA 510(k), K200404, ORISE ProKnife
FDA 510(k), K200404, ORISE ProKnife
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$149.00 USD
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$149.00 USD
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510(K) Number: K200404
Device Name: ORISE ProKnife
Manufacturer: Boston Scientific Corporation
Device Classification Name: Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Regulation Number: 876.4300
Classification Product Code: KNS
Date Received: 02/19/2020
Decision Date: 12/03/2020
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: ORISE ProKnife
Manufacturer: Boston Scientific Corporation
Device Classification Name: Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Regulation Number: 876.4300
Classification Product Code: KNS
Date Received: 02/19/2020
Decision Date: 12/03/2020
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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