FDA 510(k)

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

K-Number: K182217 · 2019-04-16

ApplicantEzisurg (Suzhou) Medical Co., Ltd.

Decision Date2019-04-16

Product CodeGDW

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Linear Cutter Staplers and Loading Units for Single Use, Circular Staplers for Single Use is a medical device manufactured by Ezisurg (Suzhou) Medical Co., Ltd.. It received FDA 510(k) clearance on 2019-04-16 under approval number K182217. 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 Linear Cutter Staplers and Loading Units for Single Use, Circular Staplers for Single Use?

Linear Cutter Staplers and Loading Units for Single Use, Circular Staplers for Single Use is a medical device that received FDA 510(k) clearance on 2019-04-16. It is manufactured by Ezisurg (Suzhou) Medical Co., Ltd.. The 510(k) number is K182217.

When was Linear Cutter Staplers and Loading Units for Single Use, Circular Staplers for Single Use approved by the FDA?

Linear Cutter Staplers and Loading Units for Single Use, Circular Staplers for Single Use received FDA 510(k) clearance on 2019-04-16, under approval number K182217.

What company makes Linear Cutter Staplers and Loading Units for Single Use, Circular Staplers for Single Use?

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

What is the FDA product code for Linear Cutter Staplers and Loading Units for Single Use, Circular Staplers for Single Use?

The FDA product code for Linear Cutter Staplers and Loading Units for Single Use, Circular Staplers for Single Use is GDW.

Related Clinical Trials

NCT06915402 Efficacy and Safety of "LMW - CL - HA - FACE/BODY" for the Augmentation of the Cheeks COMPLETED NCT07385508 Neurorehabilitation in Patients With Disorders of Consciousness: Multidimensional Ambispective Study on the Impact of Single and Combined Approaches RECRUITING NCT07592702 AI-Integrated 3D-Printed Videolaryngoscope for Orotracheal Intubation in Critically Ill Patients NOT_YET_RECRUITING NCT06832163 Close Loop Smart Weaning for INO With PPHN RECRUITING NCT07567456 Pulsatile Flushing Technique in Reducing Blockage of T-CVAD for Haemodialysis Patients RECRUITING NCT06849596 Manual T-piece Versus Ventilator Positive Pressure Ventilation During Resuscitation of Extremely Premature Neonates RECRUITING

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

K181620Endoscopic Linear Cutting Staplers and Loading Units 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.