FDA 510(k)

Arthrex BioSuture

K-Number: K220880 · 2022-10-27

Decision Date2022-10-27

Product CodeGAT

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Arthrex BioSuture is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2022-10-27 under approval number K220880. 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 BioSuture?

Arthrex BioSuture is a medical device that received FDA 510(k) clearance on 2022-10-27. It is manufactured by Arthrex, Inc.. The 510(k) number is K220880.

When was Arthrex BioSuture approved by the FDA?

Arthrex BioSuture received FDA 510(k) clearance on 2022-10-27, under approval number K220880.

What company makes Arthrex BioSuture?

Arthrex BioSuture is manufactured by Arthrex, Inc..

What is the FDA product code for Arthrex BioSuture?

The FDA product code for Arthrex BioSuture is GAT.

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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.