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FDA 510(k)

ARTHREX FIBERWIRE WITH SILK

K-Number: K041589 · 2004-08-05

ApplicantArthrex, Inc.
Decision Date2004-08-05
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ARTHREX FIBERWIRE WITH SILK is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2004-08-05 under 510(k) number K041589. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARTHREX FIBERWIRE WITH SILK?

ARTHREX FIBERWIRE WITH SILK is a medical device that received FDA 510(k) clearance on 2004-08-05. The listed applicant is Arthrex, Inc.. The 510(k) number is K041589.

When did ARTHREX FIBERWIRE WITH SILK receive FDA 510(k) clearance?

ARTHREX FIBERWIRE WITH SILK received FDA 510(k) clearance on 2004-08-05, under 510(k) number K041589.

Who is the listed applicant for ARTHREX FIBERWIRE WITH SILK?

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 FIBERWIRE WITH SILK?

The FDA product code for ARTHREX FIBERWIRE WITH SILK is GAT.

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Other records listing Arthrex, Inc. as applicant

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Related Devices (Code: GAT)

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K253910Stitch - Suture Wires and TapesGM Dos Reis Industria e Comercio Ltda.K261021EasyWhip FamilyWinter Innovations, Inc.K260775Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™Teleflex Medical, LLCK254275HyperSuture All Green Extension LineThreadstone, LLCK254188Meniscus VersaflexGM Dos Reis Industria e Comercio Ltda.K253145Pre-Sutured TendonRti Surgical, Inc.

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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