Product code GDW— General, Plastic Surgery
AEON Endoscopic Stapler
- Advisory panel
- General, Plastic Surgery
- Total cleared
- 283
Adverse events under product code GDW
product code GDW- Death
- 450
- Injury
- 12,684
- Malfunction
- 68,730
- Other
- 6
- Total
- 81,870
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code GDW
1–100 of 283- K260196 — ETHICON Circular Stapler (CDH21mm); ETHICON Circular Stapler (CDH25mm); ETHICON Circular Stapler (CDH29mm); ETHICON Circular Stapler (CDH33mm); ETHICON Circular Stapler - XL Sealed (ECS21mm); ETHICON Circular Stapler - XL Sealed (ECS25mm); ETHICON Circular Stapler - XL Sealed (ECS29mm); ETHICON Circular Stapler - XL Sealed (ECS33mm)
- K253657 — Tri-staple 2.0 Reloads; Endo GIA Reloads with Tri-Staple Technology; Endo GIA Gray Articulating Reloads; Signia Small Diameter Reloads
- K252739 — ETHICON 4000 45mm Compact Stapler (EC3DT45C); ETHICON 4000 45mm Standard Stapler (EC3DT45S); ETHICON 4000 45mm Long Stapler (EC3DT45L); ETHICON 3D 45mm White Reload (ER45W); ETHICON 3D 45mm Blue Reload (ER45B); ETHICON 3D 45mm Green Reload (ER45G); ETHICON 3D 45mm Black Reload (ER45T)
- K250835 — ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler (EC3D60S); ETHICON 4000 60mm Long Stapler (EC3D60L); ETHICON 3D 60mm White Reload (ER60W); ETHICON 3D 60mm Blue Reload (ER60B); ETHICON 3D 60mm Green Reload (ER60G); ETHICON 3D 60mm Black Reload (ER60T)
- K243276 — ECHELON LINEAR Stapler 30mm Stapler (GTX30); ECHELON LINEAR Stapler 60mm Stapler (GTX60); ECHELON LINEAR Stapler 90mm Stapler (GTX90); ECHELON LINEAR Stapler 3D 30mm Blue Reload (GTXR30B); ECHELON LINEAR Stapler 3D 30mm Green Reload (GTXR30G); ECHELON LINEAR Stapler 3D 60mm Blue Reload (GTXR60B); ECHELON LINEAR Stapler 3D 60mm Green Reload (GTXR60G); ECHELON LINEAR Stapler 3D 90mm Blue Reload (GTXR90B); ECHELON LINEAR Stapler 3D 90mm Green Reload (GTXR90G)
- K241630 — ECHELON 4000 60mm Compact Stapler (EC3D60C); ECHELON 4000 60mm Standard Stapler (EC3D60S); ECHELON 4000 60mm Long Stapler (EC3D60L); ECHELON 3D 60mm White Reload (ER60W); ECHELON 3D 60mm Blue Reload (ER60B); ECHELON 3D 60mm Green Reload (ER60G); ECHELON 3D 60mm Black Reload (ER60T)
- K242679 — Disposable 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)
- K222487 — Anika Tissue Tack Fixation System
- K222210 — AEON Endoscopic Stapler
- K223760 — ECHELON LINEAR 60 mm Cutter (GLC60);ECHELON LINEAR 80mm Cutter (GLC80);ECHELON LINEAR 100 mm Cutter (GLC100);ECHELON LINEAR Cutters 60mm Blue Reload (GLCR60B);ECHELON LINEAR Cutters 60mm Green Reload (GLCR60G);ECHELON LINEAR Cutters 80mm Blue Reload (GLCR80B);ECHELON LINEAR Cutters 80mm Green Reload (GLCR80G);ECHELON LINEAR Cutters 100mm Blue Reload (GLCR100B);ECHELON LINEAR Cutters 100mm Green Reload (GLCR100G)
- K211197 — Disposable Endoscopic Cutter Stapler and Cartridge
- K221771 — EEA Circular Stapler with Tri-Staple Technology
- K222641 — Signia Small Diameter Reloads Including Regular (Round) Tip Version
- K221003 — Autosuture EEA Stapler / circular stapler with DST Series Technology / EEA Autosuture Circular Stapler with DST Series Technology / DST Series EEA Stapler / DST EEA
- K221013 — GIA Auto Suture Stapler with DST Series Technology
- K221005 — EEA Circular Stapler with Tri-Staple Technology
- K221006 — GIA Stapler with Tri-Staple Technology
- K211811 — Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers, Disposable Circular Staplers
- K211458 — Disposable Anorectal Staplers, Disposable Intraluminal Staplers, Disposable Linear Cutting Staplers, Disposable Endoscopic Cutting Staplers
- K201934 — Surgimatix Absorbable Fixation System
- K210909 — easyEndo Lite Linear Cutting Stapler and Loading Unit for Single Use
- K201639 — Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler and Reloads, Disposable Linear Cutter Stapler and Reloads, Disposable Endoscopic Linear Cutter Stapler and Reloads
- K202709 — Disposable Powered Endoscopic Linear Cutting Staplers and Cartridges
- K210278 — Titan SGS
- K200320 — Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular Stapler, Mirus Linear Stapler and Reload
- K202507 — EEA Circular Stapler with Tri-Staple Technology
- K203117 — TissueTak device
- K202467 — Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads
- K202701 — GIA Stapler with Tri-Staple Technology
- K202864 — Tri-Staple 2.0 Reloads
- K202665 — Echelon Flex 45mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Flex 60mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Endopath Endoscopic Linear Cutter Reloads, 45mm, Echelon Endopath Endoscopic Linear Cutter Reloads, 60mm
- K201882 — AEON Endoscopic Stapler
- K201280 — Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed
- K201672 — Signia Stapler (with new software)
- K200420 — Echelon Contour Curved Cutter with blue reload, Echelon Contour Curved Cutter with green reload, Echelon Contour Curved Cutter reload, Blue, Echelon Contour Curved Cutter reload, Green
- K192720 — GIA Stapler with Tri-Staple Technology
- K192330 — EEA Circular Stapler with Tri-Staple Technology
- K190884 — TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool
- K182476 — Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads
- K190331 — Applied Medical Laparoscopic Linear Cutter
- K192566 — Reach and CQ'ENCE Circular Staplers
- K191070 — Signia Small Diameter Reloads
- K191287 — OptiFix AT Absorbable Fixation System with Articulating Technology 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology 15 Fasteners
- K182217 — Linear Cutter Staplers and Loading Units for Single Use, Circular Staplers for Single Use
- K182475 — Signia Circular Adapters (for use with Signia Staplers), Tri-Staple 2.0 Circular Reloads (for use with Signia Circular Adapters)
- K181668 — FasTouch Absorbable Fixation System
- K183477 — easyPPHTM Hemorrhoidal Stapler for Single Use
- K183435 — Echelon Endoscopic Linear Cutter Reloads, White, Blue, Gold, Green and Black
- K181657 — easyLCTM Linear Cutter Staplers and Loading Units fot Single Use; easyCSTM Circular Stapler for Single Use
- K180175 — SignalMark Lung Biopsy Site Marker
- K182380 — AEON Endoscopic Stapler
- K181620 — Endoscopic Linear Cutting Staplers and Loading Units for Single Use
- K181653 — Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed
- K173270 — Tri-Staple 2.0 Reinforced Reload
- K172361 — EEA Circular Stapler with Tri-Staple Technology
- K173443 — AEON Endoscopic Stapler
- K172960 — easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use
- K172561 — Disposable Circular Stapler
- K172538 — Disposable Linear Stapler, Disposable Linear Cutter
- K171589 — AEON Endoscopic Stapler
- K171561 — Dextera MicroCutter 30 Blue Reload, Dextera MicroCutter 30 Curved Tip Blue Reload, Dextera MicroCutter 30 White Reload, Dextera MicroCutter 30 Curved Tip White Reload
- K162707 — Single Use Circular Stapler, Single Use Hemorrhoidal Circular Stapler, Single Patient Use Linear Stapler and Reload, Single Patient Use Linear Cutter and Reload, Single Patient Use Endo Cutter and Reload, Single Patient Use Transverse Cutter and Reload
- K170278 — OptiFix AT Absorbable Fixation System with Articulating Technology - 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology - 15 Fasteners
- K163523 — ECHELON CIRCULAR Powered Stapler
- K163698 — OptiFix Open Absorbable Fixation System - 20 absorbable fasteners
- K162947 — Disposable End-to-end Anastomosis Circular Stapler; Universal Endoscopic Linear Cutting Stapler and Single Use Loading Unit; Linear Cutting Stapler and Single Use Loading Unit; Disposal Hemorrhoidal Circular Stapler
- K170348 — Signia Four-Bay Smart Charger (to be used with Signia Stapler)
- K162710 — Single Use Circular Stapler, Single Use Hemorrhodial Circular Stapler, Single Patient Use Linear Stapler and Reload, Single Patient Use Linear Cutter and Reload, Single Patient Use Endo Cutter and Reload, Single Patient Use Transverse Cutter and Reload
- K163454 — ECHELON FLEX 45mm Powered Plus Articulating Endoscopic Linear Cutters, ECHELON ENDOPATH Endoscopic Linear Cutter Reloads, 45mm
- K160969 — ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting Stapler
- K161757 — Single 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 Reloads
- K163098 — Tri-Staple 2.0 Intelligent Cartridge
- K161905 — Disposable Circular Stapler for Hemorrhoids, Disposable Circular Stapler, Disposable Linear Stapler, Disposable Endoscopic Linear Cutter Stapler and Cartridge, Disposable Linear Cutter Stapler and Stapler Cartridge
- K162252 — FasTouch Fixation System
- K161137 — Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip Reload
- K160900 — CapSure Fixation System - Straight 5mm x 37 cm 30 Permanent fasteners, CapSure Fixation System - Straight 5mm x 37 cm 15 Permanent fasteners
- K160176 — Signia Stapler
- K153202 — iMESH Tacker
- K160521 — ECHELON FLEX 60 Powered Plus Compact Articulating Endoscopic Linear Cutter, 280mm
- K151081 — MicroCutter XCHANGE 30 Stapler, MicroCutter XCHANGE 30 Blue Cartridge, MicroCutter XCHANGE 30 White Cartridge
- K152618 — PANTHER Cutter Stapler
- K151659 — ReliaTack Articulating Reloadable Fixation Device with Deep Purchase Reloadable Tacks
- K142577 — PANTHER Endo Linear Cutter Staplers with Single Use Loading Units
- K151163 — Signia Loading Unit, Tri-Staple 2.0 Cartridge
- K150026 — Endopath ETS-Flex45 Endoscopic Articulating Linear Cutter, Endopath ETS-Flex45 No-Knife Articulating Linear Stapler
- K142873 — OptiFix Fixation System - Straight 5mm X 39 cm - 30 absorbable fasteners, OptiFix Fixation System - Straight 5mm x 39 cm - 15 absorbable fasteners
- K142808 — CapSure Fixation System-Straight 5mm x 37 cm-30 Permanent fasteners, CapSure Fixation System-Straight 5mm x 37 cm-15 Permanent fasteners
- K143129 — easyEndo Linear Cutting Stapler and Loading Unit for Single Use(Stapler;Loading Unit)
- K141952 — ECHELON FLEX POWERED VASCULAR STAPLER WITH ADVANCED PLACEMENT TIP, ENDOPATH ECHELON VASCULAR WHITE RELOADS FOR ADVANCED
- K141097 — CSC SERIES INTRALUMINAL STAPLER FOR SINGLE USE
- K141367 — LS SERIES LINEAR STAPLER AND RELOADS, CLC SERIES CURVED LINEAR CUTTER AND RELOADS, LC SERIES LINEAR CUTTER AND RELOADS
- K140560 — ECHELON FLEX POWERED PLUS ARTICULATING ENDOSCOPIC LINEAR CUTTER, 60MM, STANDARD, ECHELON FLEX POWERED PLUS ARTICULATING
- K131563 — SUBQ IT! BIOABSORBABLE SKIN CLOSURE SYSTEM
- K140609 — RELIATACK ARTICULATING RELOADABLE FIXATION DEVICE WITH STANDARD PURCHASE ABSORBLE TACKS
- K132698 — FASTOUCH FIXATION SYSTEM
- K140118 — MICROCUTTER XCHANGE 30 STAPLER, MICROCUTTER XCHANGE 30 BLUE CARTRIDGE
- K140170 — MICROCUTTER XCHANGE 30 STAPLER, MICROCUTTER XCHANGE 30 WHITE CARTRIDGE
- K132472 — JUSTRIGHT 5MM STAPLER, JUSTRIGHT 5MM RELOAD
- K133938 — ENDO GIA REINFORCED RELOAD WITH TRI-STAPLE TECHNOLOGY
- K133499 — SUZHOU BEINUO SURGICAL STAPLERS - CIRCULAR STAPLERS FOR SINGLE USE, HEMORRHOIDAL CIRCULAR STAPLERS FOR SINGLE USE, LINEA
Data sourced from openFDA. This site is unofficial and independent of the FDA.