Panels › General, Plastic Surgery › Product code GDW · Class 2
Staple, Implantable
Regulation 878.4750
4510(k)s in 12 months (284 all time)
2recalls in 12 months (225 all time)
196recalls that name a 510(k)
Top companies in GDW
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 7, 2025 | Covidien, LP Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin);
BOX LOBECTOMIA VATS 3D;
CFN: BOX06170V4; Open, Classified |
GDW | K191070 |
| Nov 7, 2025 | Covidien, LP Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin);
CFN: SIGSDL45CTVT; Open, Classified |
GDW | K191070 K222641 |
| Oct 14, 2025 | Ethicon Endo-Surgery Inc ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of anastomoses, Product Number GLC80 Open, Classified |
GDW | K223760 |
| May 20, 2025 | Ethicon Endo-Surgery Inc Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); Product code VASECR35 Open, Classified |
GDW | K141952 |
| Sep 10, 2024 | Smith & Nephew Inc. ROTATION MEDICAL TENDON STAPLES (8) (narrow indication)-Intended for fixation of prosthetic material to soft tissues.
Product Number: 72205201 Open, Classified |
GDW | K131637 |
| Sep 10, 2024 | Smith & Nephew Inc. ROTATION MEDICAL TENDON STAPLES (8) (broad indication)-Intended for fixation of prosthetic material to soft tissues.
Product Number: 2504-1 Open, Classified |
GDW | K131637 |
| May 24, 2024 | Covidien, LP Tri-Staple 2.0 Black Reinforced Intelligent Reload- Applications in abdominal,
gynecologic, pediatric and thoracic surgery for resection, transection of tissue and creation of anastomosis
Model: SIGTR Open, Classified |
GDW | K173270 |
| Apr 1, 2024 | Covidien, LP Covidien Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT Open, Classified |
GDW | K191070 |
| Apr 1, 2024 | Covidien, LP Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT Open, Classified |
GDW | K191070 |
| Jan 26, 2024 | Ethicon Endo-Surgery Inc ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON Endopath Stapler, Endoscopic Linear Cutter Reload (+Gripping Surface technology), 45MM WHITE VASCULAR/THIN, Product No. Open, Classified |
GDW | K163454 |
| Mar 6, 2023 | Covidien, LP Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT Open, Classified |
GDW | K160176 |
| Jun 3, 2021 | Ethicon Endo-Surgery Inc ECHELON FLEX Powered Plus Stapler-intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, uro Terminated |
GDW | K202665 |
| Mar 23, 2021 | Covidien Llc Covidien Tri-Staple 2.0 Reinforced Intelligent Reload 60 mm Medium/Thick-For use with Signia stapling system. Staple line reinforcement has applications in abdominal, gynecologic, pediatric and thorac Terminated |
GDW | K173270 |
| Mar 4, 2021 | Covidien, LP Covidien Signia Small Diameter Curved Tip Intelligent Reload 45 mm Vascular/Thin 8 mm - Long
Item Code: SIGSDL45CTVT Terminated |
GDW | K191070 |
| Nov 23, 2020 | Covidien Llc Covidien TA Auto Suture Vascular Loading Unit with DST Series Technology 30 mm- V3. Intended for abdominal, gynecological, pediatric and thoracic surgical procedures for resection or transection of ti Completed |
GDW | K111825 |
| Nov 23, 2020 | Covidien Llc Covidien TA Auto Suture Vascular Stapler with DST Series Technology
30mm-V 3. Intended for abdominal, gynecological, pediatric and thoracic surgical procedures for resection or transection of tissue.
Completed |
GDW | K111825 |
| Aug 12, 2020 | Covidien, LP Covidien Best Practices Procedure Kits containing Auto Suture Endo GIA Universal Loading Units, Parent Codes 00Z2760 - Product Usage: The Endo GIA universal staplers have applications in abdominal, g Open, Classified |
GDW | K111825 |
| Aug 12, 2020 | Covidien, LP Endo GIA Auto Suture Universal Articulating Loading Unit 60 mm - 3.5 mm, Item Code 030458 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and t Open, Classified |
GDW | K111825 |
| Aug 12, 2020 | Covidien, LP Endo GIA Auto Suture Universal Loading Unit, Item Code 030457 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resectio Open, Classified |
GDW | K111825 |
| Aug 12, 2020 | Covidien, LP Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 3.5 mm, Item Code 030455 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and t Open, Classified |
GDW | K111825 |
| Aug 12, 2020 | Covidien, LP Endo GIA Auto Suture Universal Loading Unit 45 mm - 2.5mm, Item Code 030454 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surger Open, Classified |
GDW | K111825 |
| Aug 12, 2020 | Covidien, LP Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 2.0 mm, Item Code 030453 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and t Open, Classified |
GDW | K111825 |
| Aug 12, 2020 | Covidien, LP Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 3.5 mm, Item Code 030452 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and t Open, Classified |
GDW | K111825 |
| Aug 12, 2020 | Covidien, LP Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 2.5 mm, Item Code 030451 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and t Open, Classified |
GDW | K111825 |
| Aug 12, 2020 | Covidien, LP Endo GIA Auto Suture Gray Universal Articulating Loading Unit 30 mm - 2.0 mm, Item Code 030450 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric Open, Classified |
GDW | K111825 |
| Jan 17, 2020 | COVIDIEN LLC Covidien Endo GIA Ultra Universal Stapler 12 mm-intended for resection, transection in general surgery
Item Code: EGIAUSTND Terminated |
GDW | K111825 |
| Oct 29, 2019 | Ethicon Endo-Surgery Inc ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 340mm shaft, Product Code PSEE60A Terminated |
GDW | K140560 |
| Oct 29, 2019 | Ethicon Endo-Surgery Inc ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 440mm shaft, Product Code PLEE60A Terminated |
GDW | K140560 |
| Oct 29, 2019 | Ethicon Endo-Surgery Inc ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 280mm shaft, Product Code PCEE60A Terminated |
GDW | K160521 |
| Oct 29, 2019 | Ethicon Endo-Surgery Inc ECHELON FLEX ENDOPATH 60mm Stapler - 340mm shaft, Product Code EC60A Terminated |
GDW | K081146 |
| May 17, 2019 | Covidien LLC SIGNIA TRI-STAPLE 2.0 CURVED TIP 60MM MEDIUM/ THIC
, SIG60CTAMT Open, Classified |
GDW | K111825 K160176 |
| May 17, 2019 | Covidien LLC SIGNIA TRI-STAPLE 2.0 CURVED TIP 45MM MEDIUM/ THIC
, SIG45CTAMT Open, Classified |
GDW | K111825 K160176 |
| May 17, 2019 | Covidien LLC SIGNIA TRI-STAPLE 2.0 BLACK 60MM EXTRA THICK RELOA, SIG60AXT Open, Classified |
GDW | K111825 K160176 |
| May 17, 2019 | Covidien LLC SIGNIA TRI-STAPLE 2.0 BLACK 45MM EXTRA THICK RELOA, SIG45AXT Open, Classified |
GDW | K111825 K160176 |
| May 17, 2019 | Covidien LLC SIGNIA TRI-STAPLE 2.0 30MM MEDIUM/ THICK RELOAD
, SIG30AMT Open, Classified |
GDW | K111825 K160176 |
| May 17, 2019 | Covidien LLC EGIA45 CT AR MD THK REL, EGIA45CTAMT Open, Classified |
GDW | K111825 K160176 |
| May 17, 2019 | Covidien LLC EGIA 60 CURVED TIP ART MED THICK SULU, EGIA60CTAMT Open, Classified |
GDW | K111825 K160176 |
| May 17, 2019 | Covidien LLC EGIA 60 ARTICULATING MED THICK SULU
, EGIA60AMT Open, Classified |
GDW | K111825 K160176 |
| May 17, 2019 | Covidien LLC EGIA 60 ARTICULATING EXTRA THICK SULU, Item code EGIA60AXT Open, Classified |
GDW | K111825 K160176 |
| May 17, 2019 | Covidien LLC EGIA 45 ARTICULATING XTRA THICK SULU, Item Code EGIA45AXT Open, Classified |
GDW | K111825 K160176 |
| May 17, 2019 | Covidien LLC EGIA 45 ARTICULATING MED THICK SULU, Item Code EGIA45AMT Open, Classified |
GDW | K111825 K160176 |
| May 17, 2019 | Covidien LLC EGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT Open, Classified |
GDW | K111825 K160176 |
| Apr 11, 2019 | Ethicon Endo-Surgery Inc Straight Intraluminal Staplers, 33 mm diameter, Model SDH33A
The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrum Completed |
GDW | K983536 |
| Apr 11, 2019 | Ethicon Endo-Surgery Inc Straight Intraluminal Staplers, 29 mm diameter, Model SDH29A
The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrum Completed |
GDW | K983536 |
| Apr 11, 2019 | Ethicon Endo-Surgery Inc Straight Intraluminal Staplers, 25 mm diameter, Model SDH25A
The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrum Completed |
GDW | K983536 |
| Apr 11, 2019 | Ethicon Endo-Surgery Inc Straight Intraluminal Staplers, 21 mm diameter, Model SDH21A
The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrum Completed |
GDW | K983536 |
| Apr 11, 2019 | Ethicon Endo-Surgery Inc Endoscopic Curved Intraluminal Stapler, 33 mm diameter, Model ECS33A
The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of Completed |
GDW | K940967 K983536 |
| Apr 11, 2019 | Ethicon Endo-Surgery Inc Endoscopic Curved Intraluminal Stapler, 29 mm diameter, Model ECS29A
The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of Completed |
GDW | K940967 K983536 |
| Apr 11, 2019 | Ethicon Endo-Surgery Inc Endoscopic Curved Intraluminal Stapler, 25 mm diameter, Model ECS25A
The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of Completed |
GDW | K940967 K983536 |
| Apr 11, 2019 | Ethicon Endo-Surgery Inc Endoscopic Curved Intraluminal Stapler, 21 mm diameter, Model ECS21A
The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of Completed |
GDW | K940967 K983536 |
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