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FDA 510(k)

Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads

K-Number: K182476 · 2019-12-18

ApplicantFengh Medical Co., Ltd.
Decision Date2019-12-18
Product CodeGDW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads is a medical device manufactured by Fengh Medical Co., Ltd.. It received FDA 510(k) clearance on 2019-12-18 under approval number K182476. 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 Powered Articulating Endoscopic Linear Cutter Stapler & Reloads?

Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads is a medical device that received FDA 510(k) clearance on 2019-12-18. It is manufactured by Fengh Medical Co., Ltd.. The 510(k) number is K182476.

When was Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads approved by the FDA?

Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads received FDA 510(k) clearance on 2019-12-18, under approval number K182476.

What company makes Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads?

Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads is manufactured by Fengh Medical Co., Ltd..

What is the FDA product code for Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads?

The FDA product code for Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads is GDW.

Related Clinical Trials

NCT06691919 Surgical vs Endoscopic Resection of Walled Off Pancreatic Necrosis Using the Powered Endoscopic Debridement System WITHDRAWN NCT05360069 Linear Stapler Versus Circular Stapler in Esophagojejunostomy RECRUITING

Other Devices by Fengh Medical Co., Ltd.

K180208Disposable Endoscopic Trocar K202467Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads K242679Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (30mm series); Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (45mm series); Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (60mm series)

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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