Decision Date2019-06-18
Product CodeOAB
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
NanoKnife System is a medical device manufactured by Angiodynamics. It received FDA 510(k) clearance on 2019-06-18 under approval number K183385. The device is classified under product code OAB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the NanoKnife System?
NanoKnife System is a medical device that received FDA 510(k) clearance on 2019-06-18. It is manufactured by Angiodynamics. The 510(k) number is K183385.
When was NanoKnife System approved by the FDA?
NanoKnife System received FDA 510(k) clearance on 2019-06-18, under approval number K183385.
What company makes NanoKnife System?
NanoKnife System is manufactured by Angiodynamics.
What is the FDA product code for NanoKnife System?
The FDA product code for NanoKnife System is OAB.
Other Devices by Angiodynamics
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K242687NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15 cm (H787204001090); NanoKnife Single Electrode Activation Probe, 25 cm (H787204001100); NanoKnife Single Electrode Probe Spacer (H787204003010)AngioDynamics, Inc.
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Official Source
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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.