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FDA 510(k), K203550, ActivSight Intraoperative Imaging System
FDA 510(k), K203550, ActivSight Intraoperative Imaging System
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510(K) Number: K203550
Device Name: ActivSight Intraoperative Imaging System
Manufacturer: Activ Surgical, Inc.
Device Classification Name: confocal optical imaging
Regulation Number: 876.1500
Classification Product Code: OWN
Date Received: 12/04/2020
Decision Date: 04/08/2021
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: ActivSight Intraoperative Imaging System
Manufacturer: Activ Surgical, Inc.
Device Classification Name: confocal optical imaging
Regulation Number: 876.1500
Classification Product Code: OWN
Date Received: 12/04/2020
Decision Date: 04/08/2021
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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