FDA 510(k)

Arthrex SoftStitch

K-Number: K222078 · 2022-09-14

Decision Date2022-09-14

Product CodeGAT

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Arthrex SoftStitch is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2022-09-14 under approval 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. It is manufactured by Arthrex, Inc.. The 510(k) number is K222078.

When was Arthrex SoftStitch approved by the FDA?

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

What company makes Arthrex SoftStitch?

Arthrex SoftStitch is manufactured by Arthrex, Inc..

What is the FDA product code for Arthrex SoftStitch?

The FDA product code for Arthrex SoftStitch is GAT.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.