Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

NanoKnife System

K-Number: K183385 · 2019-06-18

ApplicantAngiodynamics
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.

Related Clinical Trials

Other Devices by Angiodynamics

Related Devices (Code: OAB)

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.