Arthrex SoftStitch
K-Number: K190707 · 2020-10-02
ApplicantArthrex, Inc.
Decision Date2020-10-02
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 2020-10-02 under approval number K190707. 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 2020-10-02. It is manufactured by Arthrex, Inc.. The 510(k) number is K190707.
When was Arthrex SoftStitch approved by the FDA?
Arthrex SoftStitch received FDA 510(k) clearance on 2020-10-02, under approval number K190707.
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.
Other Devices by Arthrex, Inc.
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.