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FDA 510(k)

ARTHREX BIOWIRE

K-Number: K091018 · 2010-07-30

ApplicantArthrex, Inc.
Decision Date2010-07-30
Product CodeGAS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ARTHREX BIOWIRE is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2010-07-30 under 510(k) number K091018. The device is classified under product code GAS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARTHREX BIOWIRE?

ARTHREX BIOWIRE is a medical device that received FDA 510(k) clearance on 2010-07-30. The listed applicant is Arthrex, Inc.. The 510(k) number is K091018.

When did ARTHREX BIOWIRE receive FDA 510(k) clearance?

ARTHREX BIOWIRE received FDA 510(k) clearance on 2010-07-30, under 510(k) number K091018.

Who is the listed applicant for ARTHREX BIOWIRE?

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 BIOWIRE?

The FDA product code for ARTHREX BIOWIRE is GAS.

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Related Devices (Code: GAS)

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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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