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FDA 510(k)

Endoscopic Linear Cutting Staplers and Loading Units for Single Use

K-Number: K181620 · 2018-09-18

ApplicantEzisurg (Suzhou) Medical Co., Ltd.
Decision Date2018-09-18
Product CodeGDW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Endoscopic Linear Cutting Staplers and Loading Units for Single Use is a medical device manufactured by Ezisurg (Suzhou) Medical Co., Ltd.. It received FDA 510(k) clearance on 2018-09-18 under approval number K181620. 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 Endoscopic Linear Cutting Staplers and Loading Units for Single Use?

Endoscopic Linear Cutting Staplers and Loading Units for Single Use is a medical device that received FDA 510(k) clearance on 2018-09-18. It is manufactured by Ezisurg (Suzhou) Medical Co., Ltd.. The 510(k) number is K181620.

When was Endoscopic Linear Cutting Staplers and Loading Units for Single Use approved by the FDA?

Endoscopic Linear Cutting Staplers and Loading Units for Single Use received FDA 510(k) clearance on 2018-09-18, under approval number K181620.

What company makes Endoscopic Linear Cutting Staplers and Loading Units for Single Use?

Endoscopic Linear Cutting Staplers and Loading Units for Single Use is manufactured by Ezisurg (Suzhou) Medical Co., Ltd..

What is the FDA product code for Endoscopic Linear Cutting Staplers and Loading Units for Single Use?

The FDA product code for Endoscopic Linear Cutting Staplers and Loading Units for Single Use is GDW.

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Other Devices by Ezisurg (Suzhou) Medical Co., Ltd.

K182217Linear Cutter Staplers and Loading Units for Single Use, Circular Staplers for Single Use

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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