FDA 510(k)

FasTouch Fixation System

K-Number: K162252 · 2016-11-14

Decision Date2016-11-14

Product CodeGDW

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

FasTouch Fixation System is a medical device manufactured by Via Surgical , Ltd.. It received FDA 510(k) clearance on 2016-11-14 under approval number K162252. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FasTouch Fixation System?

FasTouch Fixation System is a medical device that received FDA 510(k) clearance on 2016-11-14. It is manufactured by Via Surgical , Ltd.. The 510(k) number is K162252.

When was FasTouch Fixation System approved by the FDA?

FasTouch Fixation System received FDA 510(k) clearance on 2016-11-14, under approval number K162252.

What company makes FasTouch Fixation System?

FasTouch Fixation System is manufactured by Via Surgical , Ltd..

What is the FDA product code for FasTouch Fixation System?

The FDA product code for FasTouch Fixation System is GDW.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07277946 AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT07245719 Stryker Universal Midface and Upper-Face Fixation System: A Retrospective Post Market Follow Up COMPLETED NCT07485829 Zimmer Biomet-RibFix Titan RECRUITING NCT07079774 TrueLok Elevate PMCF Study RECRUITING

Other Devices by Via Surgical , Ltd.

K181668FasTouch Absorbable Fixation System K203117TissueTak device

Related Devices (Code: GDW)

K160969ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting StaplerShinemed, LLC K163098Tri-Staple 2.0 Intelligent CartridgeCovidien, LLC K161757Single Use Curved Cutters, Single Use Circular Staplers, Single Use Linear Cutters and Reloads, Single Use Endoscopic Linear Cutters and Reloads, Single Use Hemorrhoidal Staplers, Single Use Linear Staplers and ReloadsVictor Medical Instruments Co., Ltd. K161905Disposable Circular Stapler for Hemorrhoids, Disposable Circular Stapler, Disposable Linear Stapler, Disposable Endoscopic Linear Cutter Stapler and Cartridge, Disposable Linear Cutter Stapler and Stapler CartridgeChangzhou Xin Neng Yuan Medical Stapler Co.,Ltd K161137Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip ReloadCardica, Inc. K160900CapSure Fixation System - Straight 5mm x 37 cm 30 Permanent fasteners, CapSure Fixation System - Straight 5mm x 37 cm 15 Permanent fastenersC.R. Bard, 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.