Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting Stapler

K-Number: K160969 · 2016-12-12

ApplicantShinemed, LLC
Decision Date2016-12-12
Product CodeGDW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting Stapler is a medical device manufactured by Shinemed, LLC. It received FDA 510(k) clearance on 2016-12-12 under approval number K160969. 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 ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting Stapler?

ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting Stapler is a medical device that received FDA 510(k) clearance on 2016-12-12. It is manufactured by Shinemed, LLC. The 510(k) number is K160969.

When was ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting Stapler approved by the FDA?

ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting Stapler received FDA 510(k) clearance on 2016-12-12, under approval number K160969.

What company makes ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting Stapler?

ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting Stapler is manufactured by Shinemed, LLC.

What is the FDA product code for ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting Stapler?

The FDA product code for ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting Stapler is GDW.

Related Devices (Code: GDW)

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. K160900CapSure Fixation System - Straight 5mm x 37 cm – 30 Permanent fasteners, CapSure Fixation System - Straight 5mm x 37 cm – 15 Permanent fastenersC.R. Bard, 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.

↑