Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Tri-Staple 2.0 Reinforced Reload

K-Number: K173270 · 2018-02-20

ApplicantCovidien
Decision Date2018-02-20
Product CodeGDW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Tri-Staple 2.0 Reinforced Reload is a medical device manufactured by Covidien. It received FDA 510(k) clearance on 2018-02-20 under approval number K173270. 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 Tri-Staple 2.0 Reinforced Reload?

Tri-Staple 2.0 Reinforced Reload is a medical device that received FDA 510(k) clearance on 2018-02-20. It is manufactured by Covidien. The 510(k) number is K173270.

When was Tri-Staple 2.0 Reinforced Reload approved by the FDA?

Tri-Staple 2.0 Reinforced Reload received FDA 510(k) clearance on 2018-02-20, under approval number K173270.

What company makes Tri-Staple 2.0 Reinforced Reload?

Tri-Staple 2.0 Reinforced Reload is manufactured by Covidien.

What is the FDA product code for Tri-Staple 2.0 Reinforced Reload?

The FDA product code for Tri-Staple 2.0 Reinforced Reload is GDW.

Other Devices by Covidien

K163055Reprocessed Kendall SCD Express Foot Cuff K163102ReliaCatch Specimen Retrieval Bag 10mm; ReliaCatch Specimen Retrieval Bag 12mm K162941Ligasure Blunt Tip, Sealer/Divider, Nano-coated K160718Vital Sync Informatics Manager & Virtual Patient Monitoring Platform K162584VersaOne Bladeless Trocar K161804LigaSure Retractable L-Hook Laparoscopic Sealer/Divider

View all 61 devices →

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 K162252FasTouch Fixation SystemVia Surgical , Ltd. K161137Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip ReloadCardica, 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.

↑