FDA 510(k)

ARTHROCARE PERC-D SPINEWAND

K-Number: K053447 · 2005-12-27

Decision Date2005-12-27

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

ARTHROCARE PERC-D SPINEWAND is the device name listed in this FDA 510(k) record. The listed applicant is Arthrocare Corp.. It received FDA 510(k) clearance on 2005-12-27 under 510(k) number K053447. 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 ARTHROCARE PERC-D SPINEWAND?

ARTHROCARE PERC-D SPINEWAND is a medical device that received FDA 510(k) clearance on 2005-12-27. The listed applicant is Arthrocare Corp.. The 510(k) number is K053447.

When did ARTHROCARE PERC-D SPINEWAND receive FDA 510(k) clearance?

ARTHROCARE PERC-D SPINEWAND received FDA 510(k) clearance on 2005-12-27, under 510(k) number K053447.

Who is the listed applicant for ARTHROCARE PERC-D SPINEWAND?

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

What is the FDA product code for ARTHROCARE PERC-D SPINEWAND?

The FDA product code for ARTHROCARE PERC-D SPINEWAND 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.