FDA 510(k)

CONCERTO BIPOLAR NEEDLE ELECTRODE

K-Number: K060419 · 2006-03-13

Decision Date2006-03-13

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

CONCERTO BIPOLAR NEEDLE ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corp. It received FDA 510(k) clearance on 2006-03-13 under 510(k) number K060419. 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 CONCERTO BIPOLAR NEEDLE ELECTRODE?

CONCERTO BIPOLAR NEEDLE ELECTRODE is a medical device that received FDA 510(k) clearance on 2006-03-13. The listed applicant is Boston Scientific Corp. The 510(k) number is K060419.

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

CONCERTO BIPOLAR NEEDLE ELECTRODE received FDA 510(k) clearance on 2006-03-13, under 510(k) number K060419.

Who is the listed applicant for CONCERTO BIPOLAR NEEDLE ELECTRODE?

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

What is the FDA product code for CONCERTO BIPOLAR NEEDLE ELECTRODE?

The FDA product code for CONCERTO 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.