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FDA 510(k), K181745, FUJIFILM Duodenoscope Model
FDA 510(k), K181745, FUJIFILM Duodenoscope Model
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510(K) Number: K181745
Device Name: FUJIFILM Duodenoscope Model
Manufacturer: FUJIFILM Corporation
Device Classification Name: duodenoscope and accessories, flexible/rigid
Regulation Number: 876.1500
Classification Product Code: FDT
Date Received: 07/02/2018
Decision Date: 03/28/2019
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: FUJIFILM Duodenoscope Model
Manufacturer: FUJIFILM Corporation
Device Classification Name: duodenoscope and accessories, flexible/rigid
Regulation Number: 876.1500
Classification Product Code: FDT
Date Received: 07/02/2018
Decision Date: 03/28/2019
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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