FDA 510(k)

Arthrex SutureTape

K-Number: K193575 · 2020-07-24

Decision Date2020-07-24

Product CodeGAT

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Arthrex SutureTape is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2020-07-24 under approval number K193575. 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 SutureTape?

Arthrex SutureTape is a medical device that received FDA 510(k) clearance on 2020-07-24. It is manufactured by Arthrex, Inc.. The 510(k) number is K193575.

When was Arthrex SutureTape approved by the FDA?

Arthrex SutureTape received FDA 510(k) clearance on 2020-07-24, under approval number K193575.

What company makes Arthrex SutureTape?

Arthrex SutureTape is manufactured by Arthrex, Inc..

What is the FDA product code for Arthrex SutureTape?

The FDA product code for Arthrex SutureTape is GAT.

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Related Devices (Code: GAT)

K160854MaxBraid BroadBand Suture and Expressbraid BroadBand Graft Manipulation SutureBiomet Manafacturing Corp. K162247PERMATAPEMedos International SARL K162310XBraid TT Suture TapeStryker K161638SPEEDTRAP Graft Preparation SystemMedos International SARL K153089'cottony' II TAPE, PLEDGETSTeleflexmedical, Inc. K153087IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR Meniscus System, Reverse CurvedIvy Sports Medicine, LLC

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.