FDA 510(k), K171158, Single Use Electrosurgical knife
FDA 510(k), K171158, Single Use Electrosurgical knife
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510(K) Number: K171158
Device Name: Single Use Electrosurgical knife
Manufacturer: Olympus Medical Systems Corp.
Device Classification Name: unit, electrosurgical, endoscopic (with or without accessories)
Regulation Number: 876.4300
Classification Product Code: KNS
Date Received: 04/20/2017
Decision Date: 11/17/2017
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: Single Use Electrosurgical knife
Manufacturer: Olympus Medical Systems Corp.
Device Classification Name: unit, electrosurgical, endoscopic (with or without accessories)
Regulation Number: 876.4300
Classification Product Code: KNS
Date Received: 04/20/2017
Decision Date: 11/17/2017
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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