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FDA 510(k)

Arthrex LoopLoc Knotless Suture

K-Number: K212146 · 2021-10-25

ApplicantArthrex, Inc.
Decision Date2021-10-25
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Arthrex LoopLoc Knotless Suture is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2021-10-25 under approval number K212146. 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 LoopLoc Knotless Suture?

Arthrex LoopLoc Knotless Suture is a medical device that received FDA 510(k) clearance on 2021-10-25. It is manufactured by Arthrex, Inc.. The 510(k) number is K212146.

When was Arthrex LoopLoc Knotless Suture approved by the FDA?

Arthrex LoopLoc Knotless Suture received FDA 510(k) clearance on 2021-10-25, under approval number K212146.

What company makes Arthrex LoopLoc Knotless Suture?

Arthrex LoopLoc Knotless Suture is manufactured by Arthrex, Inc..

What is the FDA product code for Arthrex LoopLoc Knotless Suture?

The FDA product code for Arthrex LoopLoc Knotless Suture is GAT.

Related Clinical Trials

NCT06829667 Retrospective Study of Suture Tape for Soft Tissue Reconstruction in Patients Suffering From Lateral Ankle Instability COMPLETED NCT05753891 Trapeziectomy: Internal Brace vs. Ligament Reconstruction (Prospective) TERMINATED NCT04552119 Safety of Treatment of Shoulder Repair COMPLETED NCT07491276 Efficacy of Using Knotless Barbed Suture vs N-Butyl Cyanoacrylate Glue Tissue Adhesive for Closure of Intraoral Surgical Incisions ACTIVE_NOT_RECRUITING

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Related Devices (Code: 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.

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