FDA 510(k), K181451, URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R, URETERO-RENO FIBERSCOPE OLYMPUS URF-P7/P7R
FDA 510(k), K181451, URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R, URETERO-RENO FIBERSCOPE OLYMPUS URF-P7/P7R
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510(K) Number: K181451
Device Name: URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R, URETERO-RENO FIBERSCOPE OLYMPUS URF-P7/P7R
Manufacturer: Olympus Medical Systems Corp.
Device Classification Name: Ureteroscope And Accessories, Flexible/Rigid
Regulation Number: 876.1500
Classification Product Code: FGB
Date Received: 06/01/2018
Decision Date: 01/16/2019
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R, URETERO-RENO FIBERSCOPE OLYMPUS URF-P7/P7R
Manufacturer: Olympus Medical Systems Corp.
Device Classification Name: Ureteroscope And Accessories, Flexible/Rigid
Regulation Number: 876.1500
Classification Product Code: FGB
Date Received: 06/01/2018
Decision Date: 01/16/2019
Regulation Medical Specialty: Gastroenterology/Urology
- 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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