FDA 510(k)

ARTHROCARE SINUS ELECTROSURGERY SYSTEM

K-Number: K973478 · 1998-01-09

Decision Date1998-01-09

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

ARTHROCARE SINUS ELECTROSURGERY 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 1998-01-09 under 510(k) number K973478. 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 SINUS ELECTROSURGERY SYSTEM?

ARTHROCARE SINUS ELECTROSURGERY SYSTEM is a medical device that received FDA 510(k) clearance on 1998-01-09. The listed applicant is Arthrocare Corp.. The 510(k) number is K973478.

When did ARTHROCARE SINUS ELECTROSURGERY SYSTEM receive FDA 510(k) clearance?

ARTHROCARE SINUS ELECTROSURGERY SYSTEM received FDA 510(k) clearance on 1998-01-09, under 510(k) number K973478.

Who is the listed applicant for ARTHROCARE SINUS ELECTROSURGERY 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 SINUS ELECTROSURGERY SYSTEM?

The FDA product code for ARTHROCARE SINUS ELECTROSURGERY 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.