FDA 510(k)

MODIFICATION TO: ARTHROCARE ARTHROWANDS

K-Number: K071963 · 2007-08-07

Decision Date2007-08-07

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO: ARTHROCARE 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 2007-08-07 under 510(k) number K071963. 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: ARTHROCARE ARTHROWANDS?

MODIFICATION TO: ARTHROCARE ARTHROWANDS is a medical device that received FDA 510(k) clearance on 2007-08-07. The listed applicant is Arthrocare Corp.. The 510(k) number is K071963.

When did MODIFICATION TO: ARTHROCARE ARTHROWANDS receive FDA 510(k) clearance?

MODIFICATION TO: ARTHROCARE ARTHROWANDS received FDA 510(k) clearance on 2007-08-07, under 510(k) number K071963.

Who is the listed applicant for MODIFICATION TO: ARTHROCARE 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 MODIFICATION TO: ARTHROCARE ARTHROWANDS?

The FDA product code for MODIFICATION TO: ARTHROCARE 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.