FDA 510(k)

ENTEC EVAC PLASMA WAND

K-Number: K011279 · 2001-07-19

Decision Date2001-07-19

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

ENTEC EVAC PLASMA WAND is the device name listed in this FDA 510(k) record. The listed applicant is Arthrocare Corp.. It received FDA 510(k) clearance on 2001-07-19 under 510(k) number K011279. 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 ENTEC EVAC PLASMA WAND?

ENTEC EVAC PLASMA WAND is a medical device that received FDA 510(k) clearance on 2001-07-19. The listed applicant is Arthrocare Corp.. The 510(k) number is K011279.

When did ENTEC EVAC PLASMA WAND receive FDA 510(k) clearance?

ENTEC EVAC PLASMA WAND received FDA 510(k) clearance on 2001-07-19, under 510(k) number K011279.

Who is the listed applicant for ENTEC EVAC PLASMA WAND?

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 ENTEC EVAC PLASMA WAND?

The FDA product code for ENTEC EVAC PLASMA WAND 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.