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FDA 510(k)

Arthrex SoftStitch

K-Number: K222078 · 2022-09-14

ApplicantArthrex, Inc.
Decision Date2022-09-14
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Arthrex SoftStitch is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2022-09-14 under 510(k) number K222078. 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 SoftStitch?

Arthrex SoftStitch is a medical device that received FDA 510(k) clearance on 2022-09-14. The listed applicant is Arthrex, Inc.. The 510(k) number is K222078.

When did Arthrex SoftStitch receive FDA 510(k) clearance?

Arthrex SoftStitch received FDA 510(k) clearance on 2022-09-14, under 510(k) number K222078.

Who is the listed applicant for Arthrex SoftStitch?

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 SoftStitch?

The FDA product code for Arthrex SoftStitch is GAT.

Other records listing Arthrex, Inc. as applicant

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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.

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.K253024ProZip Knotless ImplantRiverpoint Medical

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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