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FDA 510(k)

ARTHREX FIBERWIRE, USP SIZE 5, MODEL AR-7201

K-Number: K012923 · 2001-10-04

ApplicantArthrex, Inc.
Decision Date2001-10-04
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ARTHREX FIBERWIRE, USP SIZE 5, MODEL AR-7201 is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2001-10-04 under 510(k) number K012923. 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, USP SIZE 5, MODEL AR-7201?

ARTHREX FIBERWIRE, USP SIZE 5, MODEL AR-7201 is a medical device that received FDA 510(k) clearance on 2001-10-04. The listed applicant is Arthrex, Inc.. The 510(k) number is K012923.

When did ARTHREX FIBERWIRE, USP SIZE 5, MODEL AR-7201 receive FDA 510(k) clearance?

ARTHREX FIBERWIRE, USP SIZE 5, MODEL AR-7201 received FDA 510(k) clearance on 2001-10-04, under 510(k) number K012923.

Who is the listed applicant for ARTHREX FIBERWIRE, USP SIZE 5, MODEL AR-7201?

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, USP SIZE 5, MODEL AR-7201?

The FDA product code for ARTHREX FIBERWIRE, USP SIZE 5, MODEL AR-7201 is GAT.

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Other records listing Arthrex, Inc. as applicant

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K262975Arthrex Beaming SystemK262618Arthrex Spine Compression FT ScrewK262451Arthrex DynaNite StaplesK262357Arthrex Bioabsorbable PushLock Suture AnchorsK260624Arthrex Radial Head Replacement SystemK260018Arthrex FiberButton

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Related Devices (Code: GAT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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