FDA 510(k)

MODIFICATION TO ENTEC PLASMA WANDS

K-Number: K021364 · 2002-05-30

Decision Date2002-05-30

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO ENTEC PLASMA WANDS is the device name listed in this FDA 510(k) record. The listed applicant is Arthrocare Corp.. It received FDA 510(k) clearance on 2002-05-30 under 510(k) number K021364. 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 MODIFICATION TO ENTEC PLASMA WANDS?

MODIFICATION TO ENTEC PLASMA WANDS is a medical device that received FDA 510(k) clearance on 2002-05-30. The listed applicant is Arthrocare Corp.. The 510(k) number is K021364.

When did MODIFICATION TO ENTEC PLASMA WANDS receive FDA 510(k) clearance?

MODIFICATION TO ENTEC PLASMA WANDS received FDA 510(k) clearance on 2002-05-30, under 510(k) number K021364.

Who is the listed applicant for MODIFICATION TO ENTEC PLASMA WANDS?

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 MODIFICATION TO ENTEC PLASMA WANDS?

The FDA product code for MODIFICATION TO ENTEC PLASMA WANDS 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.