FDA 510(k)

LEVEEN REFLECT MONOPOLAR/BIPOLAR NEEDLE ELECTRODE

K-Number: K011220 · 2002-07-01

Decision Date2002-07-01

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

LEVEEN REFLECT MONOPOLAR/BIPOLAR NEEDLE ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Radiotherapeutics Corp.. It received FDA 510(k) clearance on 2002-07-01 under 510(k) number K011220. 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 LEVEEN REFLECT MONOPOLAR/BIPOLAR NEEDLE ELECTRODE?

LEVEEN REFLECT MONOPOLAR/BIPOLAR NEEDLE ELECTRODE is a medical device that received FDA 510(k) clearance on 2002-07-01. The listed applicant is Radiotherapeutics Corp.. The 510(k) number is K011220.

When did LEVEEN REFLECT MONOPOLAR/BIPOLAR NEEDLE ELECTRODE receive FDA 510(k) clearance?

LEVEEN REFLECT MONOPOLAR/BIPOLAR NEEDLE ELECTRODE received FDA 510(k) clearance on 2002-07-01, under 510(k) number K011220.

Who is the listed applicant for LEVEEN REFLECT MONOPOLAR/BIPOLAR NEEDLE ELECTRODE?

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

What is the FDA product code for LEVEEN REFLECT MONOPOLAR/BIPOLAR NEEDLE ELECTRODE?

The FDA product code for LEVEEN REFLECT MONOPOLAR/BIPOLAR NEEDLE 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.