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FDA 510(k)

Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers, Disposable Circular Staplers

K-Number: K211811 · 2022-03-03

ApplicantWuxi Beien Surgery Device Co., Ltd.
Decision Date2022-03-03
Product CodeGDW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers, Disposable Circular Staplers is a medical device manufactured by Wuxi Beien Surgery Device Co., Ltd.. It received FDA 510(k) clearance on 2022-03-03 under approval number K211811. 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 Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers, Disposable Circular Staplers?

Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers, Disposable Circular Staplers is a medical device that received FDA 510(k) clearance on 2022-03-03. It is manufactured by Wuxi Beien Surgery Device Co., Ltd.. The 510(k) number is K211811.

When was Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers, Disposable Circular Staplers approved by the FDA?

Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers, Disposable Circular Staplers received FDA 510(k) clearance on 2022-03-03, under approval number K211811.

What company makes Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers, Disposable Circular Staplers?

Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers, Disposable Circular Staplers is manufactured by Wuxi Beien Surgery Device Co., Ltd..

What is the FDA product code for Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers, Disposable Circular Staplers?

The FDA product code for Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers, Disposable Circular Staplers is GDW.

Related Clinical Trials

NCT07557589 Radiofrequency Treatment for Pilonidal Disease : Clinical Investigation on Safety of Use, Efficacy and Patient Satisfaction at 6 Months RECRUITING NCT05360069 Linear Stapler Versus Circular Stapler in Esophagojejunostomy RECRUITING

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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