FDA 510(k)

ARTHROCARE ENT COBLATOR SURGERY SYSTEM

K-Number: K030108 · 2003-02-03

Decision Date2003-02-03

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

ARTHROCARE ENT COBLATOR SURGERY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Arthrocare Corp.. It received FDA 510(k) clearance on 2003-02-03 under 510(k) number K030108. 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 ENT COBLATOR SURGERY SYSTEM?

ARTHROCARE ENT COBLATOR SURGERY SYSTEM is a medical device that received FDA 510(k) clearance on 2003-02-03. The listed applicant is Arthrocare Corp.. The 510(k) number is K030108.

When did ARTHROCARE ENT COBLATOR SURGERY SYSTEM receive FDA 510(k) clearance?

ARTHROCARE ENT COBLATOR SURGERY SYSTEM received FDA 510(k) clearance on 2003-02-03, under 510(k) number K030108.

Who is the listed applicant for ARTHROCARE ENT COBLATOR SURGERY SYSTEM?

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 ENT COBLATOR SURGERY SYSTEM?

The FDA product code for ARTHROCARE ENT COBLATOR SURGERY SYSTEM 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.