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FDA 510(k)

Tri-Staple 2.0 Reloads

K-Number: K202864 · 2020-10-28

ApplicantCovidien
Decision Date2020-10-28
Product CodeGDW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Tri-Staple 2.0 Reloads is a medical device manufactured by Covidien. It received FDA 510(k) clearance on 2020-10-28 under approval number K202864. 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 Reloads?

Tri-Staple 2.0 Reloads is a medical device that received FDA 510(k) clearance on 2020-10-28. It is manufactured by Covidien. The 510(k) number is K202864.

When was Tri-Staple 2.0 Reloads approved by the FDA?

Tri-Staple 2.0 Reloads received FDA 510(k) clearance on 2020-10-28, under approval number K202864.

What company makes Tri-Staple 2.0 Reloads?

Tri-Staple 2.0 Reloads is manufactured by Covidien.

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

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

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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.

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