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FDA 510(k), K183385, NanoKnife System
FDA 510(k), K183385, NanoKnife System
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510(K) Number: K183385
Device Name: NanoKnife System
Manufacturer: Angiodynamics
Device Classification Name: Low Energy Direct Current Thermal Ablation System
Regulation Number: 878.4400
Classification Product Code: OAB
Date Received: 12/06/2018
Decision Date: 06/18/2019
Regulation Medical Specialty: General & Plastic Surgery
Device Name: NanoKnife System
Manufacturer: Angiodynamics
Device Classification Name: Low Energy Direct Current Thermal Ablation System
Regulation Number: 878.4400
Classification Product Code: OAB
Date Received: 12/06/2018
Decision Date: 06/18/2019
Regulation Medical Specialty: General & Plastic Surgery
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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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