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FDA 510(k)

Disposable Endoscopic Cutter Stapler and Cartridge

K-Number: K211197 · 2023-01-19

ApplicantChangzhou Waston Medical Appliance Co., Ltd.
Decision Date2023-01-19
Product CodeGDW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Disposable Endoscopic Cutter Stapler and Cartridge is a medical device manufactured by Changzhou Waston Medical Appliance Co., Ltd.. It received FDA 510(k) clearance on 2023-01-19 under approval number K211197. 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 Cutter Stapler and Cartridge?

Disposable Endoscopic Cutter Stapler and Cartridge is a medical device that received FDA 510(k) clearance on 2023-01-19. It is manufactured by Changzhou Waston Medical Appliance Co., Ltd.. The 510(k) number is K211197.

When was Disposable Endoscopic Cutter Stapler and Cartridge approved by the FDA?

Disposable Endoscopic Cutter Stapler and Cartridge received FDA 510(k) clearance on 2023-01-19, under approval number K211197.

What company makes Disposable Endoscopic Cutter Stapler and Cartridge?

Disposable Endoscopic Cutter Stapler and Cartridge is manufactured by Changzhou Waston Medical Appliance Co., Ltd..

What is the FDA product code for Disposable Endoscopic Cutter Stapler and Cartridge?

The FDA product code for Disposable Endoscopic Cutter Stapler and Cartridge is GDW.

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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