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FDA 510(k)

ARTHREX ASPIRATE KIT

K-Number: K062365 · 2006-09-29

ApplicantArthrex, Inc.
Decision Date2006-09-29
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ARTHREX ASPIRATE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2006-09-29 under 510(k) number K062365. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARTHREX ASPIRATE KIT?

ARTHREX ASPIRATE KIT is a medical device that received FDA 510(k) clearance on 2006-09-29. The listed applicant is Arthrex, Inc.. The 510(k) number is K062365.

When did ARTHREX ASPIRATE KIT receive FDA 510(k) clearance?

ARTHREX ASPIRATE KIT received FDA 510(k) clearance on 2006-09-29, under 510(k) number K062365.

Who is the listed applicant for ARTHREX ASPIRATE KIT?

The FDA 510(k) record lists Arthrex, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARTHREX ASPIRATE KIT?

The FDA product code for ARTHREX ASPIRATE KIT is FMF.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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