ClearanceBrief
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)
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Top companies in GDW

DateFirm and productCodeLinked 510(k)
Nov 7, 2025Covidien, LP
Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); BOX LOBECTOMIA VATS 3D; CFN: BOX06170V4;
Open, Classified
GDWK191070
Nov 7, 2025Covidien, LP
Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); CFN: SIGSDL45CTVT;
Open, Classified
GDWK191070
K222641
Oct 14, 2025Ethicon Endo-Surgery Inc
ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of anastomoses, Product Number GLC80
Open, Classified
GDWK223760
May 20, 2025Ethicon Endo-Surgery Inc
Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); Product code VASECR35
Open, Classified
GDWK141952
Sep 10, 2024Smith & Nephew Inc.
ROTATION MEDICAL TENDON STAPLES (8) (narrow indication)-Intended for fixation of prosthetic material to soft tissues. Product Number: 72205201
Open, Classified
GDWK131637
Sep 10, 2024Smith & Nephew Inc.
ROTATION MEDICAL TENDON STAPLES (8) (broad indication)-Intended for fixation of prosthetic material to soft tissues. Product Number: 2504-1
Open, Classified
GDWK131637
May 24, 2024Covidien, 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
GDWK173270
Apr 1, 2024Covidien, LP
Covidien Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT
Open, Classified
GDWK191070
Apr 1, 2024Covidien, LP
Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT
Open, Classified
GDWK191070
Jan 26, 2024Ethicon 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
GDWK163454
Mar 6, 2023Covidien, LP
Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT
Open, Classified
GDWK160176
Jun 3, 2021Ethicon 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
GDWK202665
Mar 23, 2021Covidien 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
GDWK173270
Mar 4, 2021Covidien, LP
Covidien Signia Small Diameter Curved Tip Intelligent Reload 45 mm Vascular/Thin 8 mm - Long Item Code: SIGSDL45CTVT
Terminated
GDWK191070
Nov 23, 2020Covidien 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
GDWK111825
Nov 23, 2020Covidien 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
GDWK111825
Aug 12, 2020Covidien, 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
GDWK111825
Aug 12, 2020Covidien, 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
GDWK111825
Aug 12, 2020Covidien, 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
GDWK111825
Aug 12, 2020Covidien, 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
GDWK111825
Aug 12, 2020Covidien, 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
GDWK111825
Aug 12, 2020Covidien, 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
GDWK111825
Aug 12, 2020Covidien, 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
GDWK111825
Aug 12, 2020Covidien, 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
GDWK111825
Aug 12, 2020Covidien, 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
GDWK111825
Jan 17, 2020COVIDIEN LLC
Covidien Endo GIA Ultra Universal Stapler 12 mm-intended for resection, transection in general surgery Item Code: EGIAUSTND
Terminated
GDWK111825
Oct 29, 2019Ethicon Endo-Surgery Inc
ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 340mm shaft, Product Code PSEE60A
Terminated
GDWK140560
Oct 29, 2019Ethicon Endo-Surgery Inc
ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 440mm shaft, Product Code PLEE60A
Terminated
GDWK140560
Oct 29, 2019Ethicon Endo-Surgery Inc
ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 280mm shaft, Product Code PCEE60A
Terminated
GDWK160521
Oct 29, 2019Ethicon Endo-Surgery Inc
ECHELON FLEX ENDOPATH 60mm Stapler - 340mm shaft, Product Code EC60A
Terminated
GDWK081146
May 17, 2019Covidien LLC
SIGNIA TRI-STAPLE 2.0 CURVED TIP 60MM MEDIUM/ THIC , SIG60CTAMT
Open, Classified
GDWK111825
K160176
May 17, 2019Covidien LLC
SIGNIA TRI-STAPLE 2.0 CURVED TIP 45MM MEDIUM/ THIC , SIG45CTAMT
Open, Classified
GDWK111825
K160176
May 17, 2019Covidien LLC
SIGNIA TRI-STAPLE 2.0 BLACK 60MM EXTRA THICK RELOA, SIG60AXT
Open, Classified
GDWK111825
K160176
May 17, 2019Covidien LLC
SIGNIA TRI-STAPLE 2.0 BLACK 45MM EXTRA THICK RELOA, SIG45AXT
Open, Classified
GDWK111825
K160176
May 17, 2019Covidien LLC
SIGNIA TRI-STAPLE 2.0 30MM MEDIUM/ THICK RELOAD , SIG30AMT
Open, Classified
GDWK111825
K160176
May 17, 2019Covidien LLC
EGIA45 CT AR MD THK REL, EGIA45CTAMT
Open, Classified
GDWK111825
K160176
May 17, 2019Covidien LLC
EGIA 60 CURVED TIP ART MED THICK SULU, EGIA60CTAMT
Open, Classified
GDWK111825
K160176
May 17, 2019Covidien LLC
EGIA 60 ARTICULATING MED THICK SULU , EGIA60AMT
Open, Classified
GDWK111825
K160176
May 17, 2019Covidien LLC
EGIA 60 ARTICULATING EXTRA THICK SULU, Item code EGIA60AXT
Open, Classified
GDWK111825
K160176
May 17, 2019Covidien LLC
EGIA 45 ARTICULATING XTRA THICK SULU, Item Code EGIA45AXT
Open, Classified
GDWK111825
K160176
May 17, 2019Covidien LLC
EGIA 45 ARTICULATING MED THICK SULU, Item Code EGIA45AMT
Open, Classified
GDWK111825
K160176
May 17, 2019Covidien LLC
EGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT
Open, Classified
GDWK111825
K160176
Apr 11, 2019Ethicon 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
GDWK983536
Apr 11, 2019Ethicon 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
GDWK983536
Apr 11, 2019Ethicon 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
GDWK983536
Apr 11, 2019Ethicon 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
GDWK983536
Apr 11, 2019Ethicon 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
GDWK940967
K983536
Apr 11, 2019Ethicon 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
GDWK940967
K983536
Apr 11, 2019Ethicon 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
GDWK940967
K983536
Apr 11, 2019Ethicon 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
GDWK940967
K983536

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