FDA 510(k)

ONCOBIONIC BIPOLAR ELECTRODE

K-Number: K080287 · 2008-07-03

Decision Date2008-07-03

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

ONCOBIONIC BIPOLAR ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is AngioDynamics, Inc.. It received FDA 510(k) clearance on 2008-07-03 under 510(k) number K080287. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ONCOBIONIC BIPOLAR ELECTRODE?

ONCOBIONIC BIPOLAR ELECTRODE is a medical device that received FDA 510(k) clearance on 2008-07-03. The listed applicant is AngioDynamics, Inc.. The 510(k) number is K080287.

When did ONCOBIONIC BIPOLAR ELECTRODE receive FDA 510(k) clearance?

ONCOBIONIC BIPOLAR ELECTRODE received FDA 510(k) clearance on 2008-07-03, under 510(k) number K080287.

Who is the listed applicant for ONCOBIONIC BIPOLAR ELECTRODE?

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 ONCOBIONIC BIPOLAR ELECTRODE?

The FDA product code for ONCOBIONIC BIPOLAR ELECTRODE is GEI.

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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.