FDA 510(k)

Force Fiber Suture

K-Number: K191268 · 2019-06-11

Decision Date2019-06-11

Product CodeGAT

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Force Fiber Suture is a medical device manufactured by Teleflex Medical Incorporated. It received FDA 510(k) clearance on 2019-06-11 under approval number K191268. 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 Force Fiber Suture?

Force Fiber Suture is a medical device that received FDA 510(k) clearance on 2019-06-11. It is manufactured by Teleflex Medical Incorporated. The 510(k) number is K191268.

When was Force Fiber Suture approved by the FDA?

Force Fiber Suture received FDA 510(k) clearance on 2019-06-11, under approval number K191268.

What company makes Force Fiber Suture?

Force Fiber Suture is manufactured by Teleflex Medical Incorporated.

What is the FDA product code for Force Fiber Suture?

The FDA product code for Force Fiber Suture is GAT.

Other Devices by Teleflex Medical Incorporated

K172016Force Fiber Fusion Suture K181774Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force Fiber OrthoTape suture; Bondek suture and Bondek Plus suture; Monodek suture; Polyglytone*6211 suture

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.