FDA 510(k)

SOLOIST SINGLE NEEDLE ELECTRODEELECTRODE

K-Number: K053128 · 2005-11-30

Decision Date2005-11-30

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

SOLOIST SINGLE NEEDLE ELECTRODEELECTRODE 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 2005-11-30 under 510(k) number K053128. 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 SOLOIST SINGLE NEEDLE ELECTRODEELECTRODE?

SOLOIST SINGLE NEEDLE ELECTRODEELECTRODE is a medical device that received FDA 510(k) clearance on 2005-11-30. The listed applicant is Boston Scientific Corp. The 510(k) number is K053128.

When did SOLOIST SINGLE NEEDLE ELECTRODEELECTRODE receive FDA 510(k) clearance?

SOLOIST SINGLE NEEDLE ELECTRODEELECTRODE received FDA 510(k) clearance on 2005-11-30, under 510(k) number K053128.

Who is the listed applicant for SOLOIST SINGLE NEEDLE ELECTRODEELECTRODE?

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 SOLOIST SINGLE NEEDLE ELECTRODEELECTRODE?

The FDA product code for SOLOIST SINGLE NEEDLE ELECTRODEELECTRODE 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.