GDW — Staple, Implantable Class II

FDA Device Classification

Classification Details

Product Code
GDW
Device Class
Class II
Regulation Number
878.4750
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K252739ethicon endo-surgeryETHICON™ 4000 45mm Compact Stapler (EC3DT45C); ETHICON™ 4000 45mm Standard StaplDecember 17, 2025
K250835ethicon endo-surgeryETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler May 14, 2025
K243276ethicon endo-surgeryECHELON LINEAR™ Stapler 30mm Stapler (GTX30); ECHELON LINEAR™ Stapler 60mm StaplFebruary 25, 2025
K241630ethicon endo-surgeryECHELON 4000 60mm Compact Stapler (EC3D60C); ECHELON 4000 60mm Standard Stapler October 28, 2024
K242679fengh medical coDisposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (30mmOctober 4, 2024
K222487anika therapeuticsAnika Tissue Tack Fixation SystemMay 8, 2023
K222210lexington medicalAEON Endoscopic StaplerApril 21, 2023
K223760ethicon endo-surgeryECHELON LINEAR™ 60 mm Cutter (GLC60);ECHELON LINEAR™ 80mm Cutter (GLC80);ECHELOMarch 15, 2023
K211197changzhou waston medical appliance coDisposable Endoscopic Cutter Stapler and CartridgeJanuary 19, 2023
K221771covidienEEA Circular Stapler with Tri-Staple TechnologyNovember 30, 2022
K222641covidienSignia™ Small Diameter Reloads Including Regular (Round) Tip VersionNovember 29, 2022
K221003covidienAutosuture EEA Stapler / circular stapler with DST Series Technology / EEA AutosSeptember 30, 2022
K221013covidienGIA Auto Suture Stapler with DST Series TechnologyMay 5, 2022
K221006covidienGIA Stapler with Tri-Staple TechnologyApril 29, 2022
K221005covidienEEA Circular Stapler with Tri-Staple TechnologyApril 29, 2022
K211811wuxi beien surgery device coDisposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter SMarch 3, 2022
K211458ningbo verykind medical device coDisposable Anorectal Staplers, Disposable Intraluminal Staplers, Disposable LineDecember 30, 2021
K201934surgimatixSurgimatix Absorbable Fixation SystemOctober 1, 2021
K210909ezisurg medical coeasyEndo Lite Linear Cutting Stapler and Loading Unit for Single UseJune 24, 2021
K201639beijing biosis healing biolog ical technology coDisposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear SMay 27, 2021