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FDA 510(k)

Disposable Circular Stapler

K-Number: K172561 · 2017-12-05

ApplicantChangzhou Kangdi Medical Stapler Co., Ltd.
Decision Date2017-12-05
Product CodeGDW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Disposable Circular Stapler is a medical device manufactured by Changzhou Kangdi Medical Stapler Co., Ltd.. It received FDA 510(k) clearance on 2017-12-05 under approval number K172561. 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 Circular Stapler?

Disposable Circular Stapler is a medical device that received FDA 510(k) clearance on 2017-12-05. It is manufactured by Changzhou Kangdi Medical Stapler Co., Ltd.. The 510(k) number is K172561.

When was Disposable Circular Stapler approved by the FDA?

Disposable Circular Stapler received FDA 510(k) clearance on 2017-12-05, under approval number K172561.

What company makes Disposable Circular Stapler?

Disposable Circular Stapler is manufactured by Changzhou Kangdi Medical Stapler Co., Ltd..

What is the FDA product code for Disposable Circular Stapler?

The FDA product code for Disposable Circular Stapler is GDW.

Related Clinical Trials

NCT05360069 Linear Stapler Versus Circular Stapler in Esophagojejunostomy RECRUITING

Other Devices by Changzhou Kangdi Medical Stapler Co., Ltd.

K172538Disposable Linear Stapler, Disposable Linear Cutter

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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