FDA 510(k)

ARTHROCARE SYSTEM 15000 CONTROLLER, ARTHROWANDS

K-Number: K093165 · 2009-12-04

Decision Date2009-12-04

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

ARTHROCARE SYSTEM 15000 CONTROLLER, ARTHROWANDS is the device name listed in this FDA 510(k) record. The listed applicant is Arthrocare Corp.. It received FDA 510(k) clearance on 2009-12-04 under 510(k) number K093165. 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 SYSTEM 15000 CONTROLLER, ARTHROWANDS?

ARTHROCARE SYSTEM 15000 CONTROLLER, ARTHROWANDS is a medical device that received FDA 510(k) clearance on 2009-12-04. The listed applicant is Arthrocare Corp.. The 510(k) number is K093165.

When did ARTHROCARE SYSTEM 15000 CONTROLLER, ARTHROWANDS receive FDA 510(k) clearance?

ARTHROCARE SYSTEM 15000 CONTROLLER, ARTHROWANDS received FDA 510(k) clearance on 2009-12-04, under 510(k) number K093165.

Who is the listed applicant for ARTHROCARE SYSTEM 15000 CONTROLLER, ARTHROWANDS?

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 SYSTEM 15000 CONTROLLER, ARTHROWANDS?

The FDA product code for ARTHROCARE SYSTEM 15000 CONTROLLER, ARTHROWANDS 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.