510(k) K111825 ยท GDW Staple, Implantable
ENDO GIA(TM) STAPLERS, DST SERIES(TM) GIA(TM) STAPLERS, DST SERIES(TM) TA(TM) STAPLERS
| Applicant | Covidien, Formerly US Surgical A Divison of Tyco H, North Haven CT, US |
| Decision | Substantially Equivalent, Oct 25, 2011 |
| Received | Jun 28, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111825
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| May 17, 2019 | Covidien LLC EGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT Open, Classified |
GDW | None listed |
| May 17, 2019 | Covidien LLC EGIA 45 ARTICULATING MED THICK SULU, Item Code EGIA45AMT Open, Classified |
GDW | None listed |
| May 17, 2019 | Covidien LLC EGIA 45 ARTICULATING XTRA THICK SULU, Item Code EGIA45AXT Open, Classified |
GDW | None listed |
| May 17, 2019 | Covidien LLC EGIA 60 ARTICULATING EXTRA THICK SULU, Item code EGIA60AXT Open, Classified |
GDW | None listed |
| May 17, 2019 | Covidien LLC EGIA 60 ARTICULATING MED THICK SULU
, EGIA60AMT Open, Classified |
GDW | None listed |
| May 17, 2019 | Covidien LLC EGIA 60 CURVED TIP ART MED THICK SULU, EGIA60CTAMT Open, Classified |
GDW | None listed |
| May 17, 2019 | Covidien LLC EGIA45 CT AR MD THK REL, EGIA45CTAMT Open, Classified |
GDW | None listed |
| May 17, 2019 | Covidien LLC SIGNIA TRI-STAPLE 2.0 30MM MEDIUM/ THICK RELOAD
, SIG30AMT Open, Classified |
GDW | None listed |
| May 17, 2019 | Covidien LLC SIGNIA TRI-STAPLE 2.0 BLACK 45MM EXTRA THICK RELOA, SIG45AXT Open, Classified |
GDW | None listed |
| May 17, 2019 | Covidien LLC SIGNIA TRI-STAPLE 2.0 BLACK 60MM EXTRA THICK RELOA, SIG60AXT Open, Classified |
GDW | None listed |
| May 17, 2019 | Covidien LLC SIGNIA TRI-STAPLE 2.0 CURVED TIP 45MM MEDIUM/ THIC
, SIG45CTAMT Open, Classified |
GDW | None listed |
| May 17, 2019 | Covidien LLC SIGNIA TRI-STAPLE 2.0 CURVED TIP 60MM MEDIUM/ THIC
, SIG60CTAMT Open, Classified |
GDW | None listed |
| Jul 19, 2018 | COVIDIEN MEDTRONIC Endo GIA 45 mm Articulating Medium/Thick Reload with Tri-Staple Technology, Item Code EGIA45AMT Open, Classified |
GDW | None listed |
| Jul 19, 2018 | COVIDIEN MEDTRONIC Endo GIA 60 mm Articulating Medium/Thick Reload with Tri-StapleTechnology, Item Code EGIA60AMT Open, Classified |
GDW | None listed |
| Jul 19, 2018 | COVIDIEN MEDTRONIC Endo GIA 60 mm Extra Thick Black Articulating Reload with Tri-Staple Technology, Item Code EGIA60AXT Open, Classified |
GDW | None listed |
| May 16, 2018 | COVIDIEN MEDTRONIC Endo GIA" Auto Suture" Universal Articulating Loading Unit 30mm- 2.0mm ( Item Code 030450)
Product Usage:
The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows Terminated |
GDW | None listed |
| May 16, 2018 | COVIDIEN MEDTRONIC Endo GIA" Auto Suture" Universal Articulating Loading Unit 30mm - 2.5mm ( Item Code 030451)
Product Usage:
The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered row Terminated |
GDW | None listed |
| May 16, 2018 | COVIDIEN MEDTRONIC Endo GIA" Auto Suture" Universal Articulating Loading Unit 30mm - 3.5mm ( Item Code 030452)
Product Usage:
The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered row Terminated |
GDW | None listed |
| May 16, 2018 | COVIDIEN MEDTRONIC Endo GIA" Auto Suture" Universal Articulating Loading Unit 45mm - 2.5mm( Item Code 030454)
Product Usage:
The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered ro Terminated |
GDW | None listed |
| May 16, 2018 | COVIDIEN MEDTRONIC Endo GIA" Auto Suture" Universal Articulating Loading Unit 45mm- 3.5mm( Item Code 030455)
Product Usage:
The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows Terminated |
GDW | None listed |
| May 16, 2018 | COVIDIEN MEDTRONIC Endo GIA" Auto Suture" Universal Articulating Loading Unit 60mm -2.5mm ( Item Code 030457)
Product Usage:
The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows Terminated |
GDW | None listed |
| May 16, 2018 | COVIDIEN MEDTRONIC Endo GIA" Auto Suture" Universal Articulating Loading Unit 60mm - 3.5mm ( Item Code 030458)
Product Usage:
The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered row Terminated |
GDW | None listed |
| May 16, 2018 | COVIDIEN MEDTRONIC Endo GIA" 30mm Gray Curved Tip Articulating Vascular Reload with Tri-Staple" Technology( Item Code EGIA30CTAV)
Product Usage:
The Endo GIA universal and Endo GIA universal XL staplers place two, tr Terminated |
GDW | None listed |
| May 16, 2018 | COVIDIEN MEDTRONIC Endo GIA" 30mm Gray Curved Tip Articulating Vascular Reload with Tri-Staple" Technology( Item Code EGIA30AV)
Product Usage:
The Endo GIA universal and Endo GIA universal XL staplers place two, trip Terminated |
GDW | None listed |
| May 16, 2018 | COVIDIEN MEDTRONIC Endo GIA" 45mm Gray Curved Tip Articulating Vascular Reload with Tri-Staple" Technology( Item Code EGIA45CTAV)
Product Usage:
The Endo GIA universal and Endo GIA universal XL staplers place two, tr Terminated |
GDW | None listed |
| May 16, 2018 | COVIDIEN MEDTRONIC Covidien" Best Practices" Procedure Kits containing Auto Suture" Endo GIA" Devices
Product Usage:
The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of tit Terminated |
GDW | None listed |
| May 16, 2018 | COVIDIEN MEDTRONIC BOX KIT1095V KIT OBESITAS (Item Code KIT1095V)
Product Usage:
The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divide Terminated |
GDW | None listed |
| May 16, 2018 | COVIDIEN MEDTRONIC (1) BOX 01KBAR006116V PROC BYPASS 01KBAR0061(Item Code 01KBAR006116V PROC BYPAS)
(2) BOX 1073076GASB0 BBR STVEIT GASTRIC B (Item Code BOX1073076GASB0)
(3) BOX BOX1073076GASB0 BBR STVEIT GASTRIC Terminated |
GDW | None listed |
| May 16, 2018 | COVIDIEN MEDTRONIC BOX1073076GASB1 BBR GASTRIC BYPASS S(Item Code BOX1073076GASB1 BBR GASTRIC BYPASS S)
Product Usage:
The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of tita Terminated |
GDW | None listed |
| May 16, 2018 | COVIDIEN MEDTRONIC (1) BOX BOX1073180 APPE1 APPENDIX KIT ZAMS
(Item Code BOX1073180)
(2)BOX BOX1073180APPE1 APPENDIX KIT ZAMS
(Item Code BOX1073180APPE1 APPENDIX KIT ZAMS)
Product Usage:
The Endo GIA Terminated |
GDW | None listed |
| May 16, 2018 | COVIDIEN MEDTRONIC (1)BOX HEMIGX1 ZESTAW DO HEMICOLECTOMII
(Item Number HEMIGX1 ZESTAW DO HEMICOLECTOMII)
(2) BOX LAPPH ZASTAW DO PRAWEJ HEMIKOLEKTOMI
(item number: LAPPH ZASTAW DO PRAWEJ HEMIKOLEKTOMI
Product Terminated |
GDW | None listed |
| May 16, 2018 | COVIDIEN MEDTRONIC KIT00486R OBESIDAD D. WORWARLD 2 X1
(Item Number KIT00486R)
Product Usage:
The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples Terminated |
GDW | None listed |
| May 16, 2018 | COVIDIEN MEDTRONIC BOX KIT00713 KIT BY PASS
Product Usage:
The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between Terminated |
GDW | None listed |
| May 16, 2018 | COVIDIEN MEDTRONIC BOX KIT00714 KIT SLEEVE
Product Usage:
The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between t Terminated |
GDW | None listed |
| May 16, 2018 | COVIDIEN MEDTRONIC BOX KIT1171C KIT LAP CYSTECTOMY
Product Usage:
The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue b Terminated |
GDW | None listed |
| May 16, 2018 | COVIDIEN MEDTRONIC KIT-DE-0080 BYPASS KIT LOHNE X1( Item KIT-DE-0080)
Product Usage:
The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously d Terminated |
GDW | None listed |
| May 16, 2018 | COVIDIEN MEDTRONIC (1)KIT4184 APEN LOBECTOMY KIT X0
Item Number: KIT4184 APEN LOBECTOMY KIT XO
(2) BOX VATSLOB11 ZESTAW DO VATS LOBECTOMII
(Item Number: VATSLOB11, VATSLOB11 ZESTAW DO VATS LOBECTOMII
P Terminated |
GDW | None listed |
| May 16, 2018 | COVIDIEN MEDTRONIC BOX KITDE0108 BYPASS KIT LUEBECK ( KITDE0108)
Product Usage:
The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divide Terminated |
GDW | None listed |
| May 16, 2018 | COVIDIEN MEDTRONIC (1) BOX KITDE0143 BYPASS BOX (Item Number: KITDE0143,
KITDE0143 BYPASS BOX)
(2) BOX KITDE0154 BYPASS KH NORDWEST
(Item Number: KITDE0154, KITDE0154 BYPASS KH NORDWEST
Product Usage: Terminated |
GDW | None listed |
| May 16, 2018 | COVIDIEN MEDTRONIC (1)BOX KITDE0183 APPENDIX LIPPE DETMOLD (KITDE0183)
(2) KIT-DE-0083 APPENEKTOMIE KIT NAUENX1
(Item Number: KIT-DE-0083,KIT-DE-0083 APPENEKTOMIE KIT NAUENX1
Product Usage:
The Endo GIA universal an Terminated |
GDW | None listed |
| May 16, 2018 | COVIDIEN MEDTRONIC (1)LAPBARLECZNA ZESTAW BARIATRYCZNY LECZNA
(2) KITBAR021- BARIATRIC KIT X1
Item Code:KITBAR021- BARIATRIC KIT X0
(3)BOX SGGLOGX1 ZESTAW DO BARIATRII
Item Code: SGGLOGX1 ZESTAW DO BARIATRII
( Terminated |
GDW | None listed |
| May 16, 2018 | COVIDIEN MEDTRONIC BOX LAPIMBGP1 ZESTAW DO MGBP (LAPIMBGP1)
Product Usage:
The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides th Terminated |
GDW | None listed |
| May 16, 2018 | COVIDIEN MEDTRONIC (1) BOX LAPZD ZESTAW DO SG
(2) BOX LAPISG1 ZESTAW DO SG
(3) BOX LAPISGW ZESTAW DO SG
Product Usage:
The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggere Terminated |
GDW | None listed |
| May 16, 2018 | COVIDIEN MEDTRONIC BOX MGBGLOGX1 ZESTAW MINI GASTRIC BYPASS
Product Usage:
The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the Terminated |
GDW | None listed |
| May 16, 2018 | COVIDIEN MEDTRONIC (1)BOX PST01199 BARIATRIC TRISTAPLE (Item Number: PST01199)
(2) BOX PST03403 ALTERNATIVE APPENDIX KIT (Item Number: PST03403)
(3) BOX PST03533 KIT APP STAPLER (Item Number Terminated |
GDW | None listed |
| May 16, 2018 | COVIDIEN MEDTRONIC MGBX ZESTAW GB LS X1
Product Usage:
The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the Terminated |
GDW | None listed |
| May 16, 2018 | COVIDIEN MEDTRONIC BOX PST03533 KIT APP STAPLER
Product Usage:
The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue betw Terminated |
GDW | None listed |
| May 16, 2018 | COVIDIEN MEDTRONIC BOX PST03699 KIT APP MED ALTERNATIV STAP
Product Usage:
The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the Terminated |
GDW | None listed |
| May 16, 2018 | COVIDIEN MEDTRONIC (1)BOX PST04089 SLEEVE AIWA CLINIC
Item Number:PST04089 SLEEVE AIWA CLINIC
(2)BOX PST04090 BYPASS AIWA CLINIC
Item Number: PST04090 BYPASS AIWA CLINIC
Product Usage: Terminated |
GDW | None listed |
| May 16, 2018 | COVIDIEN MEDTRONIC SLEEVEGK1 ZESTAW DO ZABIEGOW SLEEVEX1
Product Usage:
The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the ti Terminated |
GDW | None listed |
| May 16, 2018 | COVIDIEN MEDTRONIC (1)BOX SLEEVEGK3
(2) BOX SLEEVEGK4 SLEEVE GASTRECTOMY
(3)BOX SLEEVEJAWI SLEEVE GASTRECTOMY BOX
(4) SSLEEVE ZEST DO SLEEVE GASTREKTOMIIX1
Product Usage:
The Endo GIA universal Terminated |
GDW | None listed |
| May 16, 2018 | COVIDIEN MEDTRONIC BOX TGGLOGOWX1 DO TOTAL GASTRECTOMIII
Product Usage:
The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the ti Terminated |
GDW | None listed |
| May 16, 2018 | COVIDIEN MEDTRONIC BOX VATS1SCDX DO ZABIEGOW VATS
Product Usage:
The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue be Terminated |
GDW | None listed |
| May 16, 2018 | COVIDIEN MEDTRONIC BOX VMIN ZESTAW DO VATS PODSTAWOWY
Product Usage:
The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissu Terminated |
GDW | None listed |
| May 16, 2018 | COVIDIEN MEDTRONIC BOX VWR ZESTAW DO VATS KLIN
Product Usage:
The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue betwe Terminated |
GDW | None listed |
| Feb 16, 2018 | Covidien LLC Endo GIA Auto Suture Universal Articulating Loading Unit for use in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. Terminated |
GDW | None listed |
| Feb 18, 2016 | Medtronic Covidien Endo GIA Ultra Universal 12 mm Short Stapler Handle
Ref: EGIAUSHORT
Product Usage:
The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers have Terminated |
GDW | None listed |
| Feb 18, 2016 | Medtronic Covidien Endo GIA Ultra Universal Standard Stapler Handle
Ref: EGIAUSTND
Product Usage:
The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers have appl Terminated |
GDW | None listed |
| Feb 18, 2016 | Medtronic Covidien Endo GIA Ultra Universal 12 mm XL Stapler Handle
Ref: EGIAUXL
Product Usage:
The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers have applic Terminated |
GDW | None listed |
| Feb 18, 2016 | Medtronic Best Practice Kits containing certain production lots of Endo GIA Ultra Universal Stapler Handles
Product Usage:
The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Univer Terminated |
GDW | None listed |
| Apr 5, 2013 | Covidien LP Covidien Endo GIA AutoSuture Universal Loading Unit, 30mm-2.0mm
Product Code: 030450
Applications in abdominal, gynecologic, pediatric anti thoracic surgery for resection Terminated |
GDW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.