FDA 510(k)

NANOKNIFE SYSTEM

K-Number: K102329 · 2011-10-24

Decision Date2011-10-24

Product CodeOAB

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

NANOKNIFE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is AngioDynamics, Inc.. It received FDA 510(k) clearance on 2011-10-24 under 510(k) number K102329. 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 2011-10-24. The listed applicant is AngioDynamics, Inc.. The 510(k) number is K102329.

When did NANOKNIFE SYSTEM receive FDA 510(k) clearance?

NANOKNIFE SYSTEM received FDA 510(k) clearance on 2011-10-24, under 510(k) number K102329.

Who is the listed applicant for NANOKNIFE SYSTEM?

The FDA 510(k) record lists AngioDynamics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NANOKNIFE SYSTEM?

The FDA product code for NANOKNIFE SYSTEM is OAB.

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Official Source

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