FDA 510(k)

ARTHROCARE IRRIGATION PUMP, MODEL SIP001-00, SIP001-01

K-Number: K080482 · 2008-03-20

Decision Date2008-03-20

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

ARTHROCARE IRRIGATION PUMP, MODEL SIP001-00, SIP001-01 is the device name listed in this FDA 510(k) record. The listed applicant is Arthrocare Corp.. It received FDA 510(k) clearance on 2008-03-20 under 510(k) number K080482. 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 IRRIGATION PUMP, MODEL SIP001-00, SIP001-01?

ARTHROCARE IRRIGATION PUMP, MODEL SIP001-00, SIP001-01 is a medical device that received FDA 510(k) clearance on 2008-03-20. The listed applicant is Arthrocare Corp.. The 510(k) number is K080482.

When did ARTHROCARE IRRIGATION PUMP, MODEL SIP001-00, SIP001-01 receive FDA 510(k) clearance?

ARTHROCARE IRRIGATION PUMP, MODEL SIP001-00, SIP001-01 received FDA 510(k) clearance on 2008-03-20, under 510(k) number K080482.

Who is the listed applicant for ARTHROCARE IRRIGATION PUMP, MODEL SIP001-00, SIP001-01?

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 IRRIGATION PUMP, MODEL SIP001-00, SIP001-01?

The FDA product code for ARTHROCARE IRRIGATION PUMP, MODEL SIP001-00, SIP001-01 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.