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FDA 510(k)

XBraid TT Suture Tape

K-Number: K162310 · 2016-11-10

ApplicantStryker
Decision Date2016-11-10
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

XBraid TT Suture Tape is a medical device manufactured by Stryker. It received FDA 510(k) clearance on 2016-11-10 under approval number K162310. 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 XBraid TT Suture Tape?

XBraid TT Suture Tape is a medical device that received FDA 510(k) clearance on 2016-11-10. It is manufactured by Stryker. The 510(k) number is K162310.

When was XBraid TT Suture Tape approved by the FDA?

XBraid TT Suture Tape received FDA 510(k) clearance on 2016-11-10, under approval number K162310.

What company makes XBraid TT Suture Tape?

XBraid TT Suture Tape is manufactured by Stryker.

What is the FDA product code for XBraid TT Suture Tape?

The FDA product code for XBraid TT Suture Tape is GAT.

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Related Devices (Code: GAT)

K160854MaxBraid BroadBand Suture and Expressbraid BroadBand Graft Manipulation SutureBiomet Manafacturing Corp. K162247PERMATAPEMedos International SARL 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 K153076silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX Gabbay-Frater, NYLON, SILK, STAINLESS STEELTeleflexmedical, Inc.

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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