FDA 510(k)

SutureTape

K-Number: K171296 · 2017-05-26

Decision Date2017-05-26

Product CodeGAT

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

SutureTape is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2017-05-26 under approval number K171296. 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 SutureTape?

SutureTape is a medical device that received FDA 510(k) clearance on 2017-05-26. It is manufactured by Arthrex, Inc.. The 510(k) number is K171296.

When was SutureTape approved by the FDA?

SutureTape received FDA 510(k) clearance on 2017-05-26, under approval number K171296.

What company makes SutureTape?

SutureTape is manufactured by Arthrex, Inc..

What is the FDA product code for SutureTape?

The FDA product code for SutureTape is GAT.

Other Devices by Arthrex, Inc.

K161060Arthrex iBalance UKA System Vitamin E Tibial Bearing K161782Arthrex Univers Revers Shoulder Prosthesis System K161581Arthrex Synergy RF System K161108Arthrex VaultLock Glenoid K160319FiberTak DR K151527Arthrex Univers Revers CA Heads and Adapters

View all 168 devices →

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.