Atlas FDA

ENDO GIA(TM) STAPLERS, DST SERIES(TM) GIA(TM) STAPLERS, DST SERIES(TM) TA(TM) STAPLERS

FDA 510(k) clearance K111825 · decided 2011-10-25

Clearance details

K-number
K111825
Device name
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
Decision
Substantially Equivalent
Date received
2011-06-28
Decision date
2011-10-25
Days to decision
119 days
Clearance type
Traditional
Product code
GDW
Device class
2
Regulation number
878.4750
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
North Haven, CT, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Endo GIA 45 mm Articulating Medium/Thick Reload with Tri-Staple Technology, Item Code EGIA recall (Z-2503-2018)COVIDIEN MEDTRONIC2018-07-19
Endo GIA 60 mm Articulating Medium/Thick Reload with Tri-StapleTechnology, Item Code EGIA6 recall (Z-2504-2018)COVIDIEN MEDTRONIC2018-07-19
Endo GIA 60 mm Extra Thick Black Articulating Reload with Tri-Staple Technology, Item Code recall (Z-2505-2018)COVIDIEN MEDTRONIC2018-07-19
Endo GIA" Auto Suture" Universal Articulating Loading Unit 30mm- 2.0mm ( Item Code 030450) recall (Z-1814-2018)COVIDIEN MEDTRONIC2018-05-16
Endo GIA" Auto Suture" Universal Articulating Loading Unit 30mm - 2.5mm ( Item Code 030451 recall (Z-1815-2018)COVIDIEN MEDTRONIC2018-05-16
Endo GIA" Auto Suture" Universal Articulating Loading Unit 30mm - 3.5mm ( Item Code 030452 recall (Z-1816-2018)COVIDIEN MEDTRONIC2018-05-16
Endo GIA" Auto Suture" Universal Articulating Loading Unit 45mm - 2.5mm( Item Code 030454) recall (Z-1817-2018)COVIDIEN MEDTRONIC2018-05-16
Endo GIA" Auto Suture" Universal Articulating Loading Unit 45mm- 3.5mm( Item Code 030455) recall (Z-1818-2018)COVIDIEN MEDTRONIC2018-05-16
Endo GIA" Auto Suture" Universal Articulating Loading Unit 60mm -2.5mm ( Item Code 030457) recall (Z-1819-2018)COVIDIEN MEDTRONIC2018-05-16
Endo GIA" Auto Suture" Universal Articulating Loading Unit 60mm - 3.5mm ( Item Code 030458 recall (Z-1820-2018)COVIDIEN MEDTRONIC2018-05-16
Endo GIA" 30mm Gray Curved Tip Articulating Vascular Reload with Tri-Staple" Technology( I recall (Z-1821-2018)COVIDIEN MEDTRONIC2018-05-16
Endo GIA" 30mm Gray Curved Tip Articulating Vascular Reload with Tri-Staple" Technology( I recall (Z-1822-2018)COVIDIEN MEDTRONIC2018-05-16
Endo GIA" 45mm Gray Curved Tip Articulating Vascular Reload with Tri-Staple" Technology( I recall (Z-1823-2018)COVIDIEN MEDTRONIC2018-05-16
Covidien" Best Practices" Procedure Kits containing Auto Suture" Endo GIA" Devices Product recall (Z-1824-2018)COVIDIEN MEDTRONIC2018-05-16
BOX KIT1095V KIT OBESITAS (Item Code KIT1095V) Product Usage: The Endo GIA universal and E recall (Z-1825-2018)COVIDIEN MEDTRONIC2018-05-16
(1) BOX 01KBAR006116V PROC BYPASS 01KBAR0061(Item Code 01KBAR006116V PROC BYPAS) (2) BOX 1 recall (Z-1826-2018)COVIDIEN MEDTRONIC2018-05-16
BOX1073076GASB1 BBR GASTRIC BYPASS S(Item Code BOX1073076GASB1 BBR GASTRIC BYPASS S) Produ recall (Z-1828-2018)COVIDIEN MEDTRONIC2018-05-16
(1) BOX BOX1073180 APPE1 APPENDIX KIT ZAMS (Item Code BOX1073180) (2)BOX BOX1073180APPE1 A recall (Z-1829-2018)COVIDIEN MEDTRONIC2018-05-16
(1)BOX HEMIGX1 ZESTAW DO HEMICOLECTOMII (Item Number HEMIGX1 ZESTAW DO HEMICOLECTOMII) (2) recall (Z-1830-2018)COVIDIEN MEDTRONIC2018-05-16
KIT00486R OBESIDAD D. WORWARLD 2 X1 (Item Number KIT00486R) Product Usage: The Endo GIA un recall (Z-1831-2018)COVIDIEN MEDTRONIC2018-05-16
BOX KIT00713 KIT BY PASS Product Usage: The Endo GIA universal and Endo GIA universal XL s recall (Z-1832-2018)COVIDIEN MEDTRONIC2018-05-16
BOX KIT00714 KIT SLEEVE Product Usage: The Endo GIA universal and Endo GIA universal XL st recall (Z-1833-2018)COVIDIEN MEDTRONIC2018-05-16
BOX KIT1171C KIT LAP CYSTECTOMY Product Usage: The Endo GIA universal and Endo GIA univers recall (Z-1834-2018)COVIDIEN MEDTRONIC2018-05-16
KIT-DE-0080 BYPASS KIT LOHNE X1( Item KIT-DE-0080) Product Usage: The Endo GIA universal a recall (Z-1837-2018)COVIDIEN MEDTRONIC2018-05-16
(1)KIT4184 APEN LOBECTOMY KIT X0 Item Number: KIT4184 APEN LOBECTOMY KIT XO (2) BOX VATSLO recall (Z-1838-2018)COVIDIEN MEDTRONIC2018-05-16
BOX KITDE0108 BYPASS KIT LUEBECK ( KITDE0108) Product Usage: The Endo GIA universal and En recall (Z-1839-2018)COVIDIEN MEDTRONIC2018-05-16
(1) BOX KITDE0143 BYPASS BOX (Item Number: KITDE0143, KITDE0143 BYPASS BOX) (2) BOX KITDE0 recall (Z-1840-2018)COVIDIEN MEDTRONIC2018-05-16
(1)BOX KITDE0183 APPENDIX LIPPE DETMOLD (KITDE0183) (2) KIT-DE-0083 APPENEKTOMIE KIT NAUEN recall (Z-1842-2018)COVIDIEN MEDTRONIC2018-05-16
(1)LAPBARLECZNA ZESTAW BARIATRYCZNY LECZNA (2) KITBAR021- BARIATRIC KIT X1 Item Code:KITBA recall (Z-1843-2018)COVIDIEN MEDTRONIC2018-05-16
BOX LAPIMBGP1 ZESTAW DO MGBP (LAPIMBGP1) Product Usage: The Endo GIA universal and Endo GI recall (Z-1844-2018)COVIDIEN MEDTRONIC2018-05-16
(1) BOX LAPZD ZESTAW DO SG (2) BOX LAPISG1 ZESTAW DO SG (3) BOX LAPISGW ZESTAW DO SG Produ recall (Z-1847-2018)COVIDIEN MEDTRONIC2018-05-16
BOX MGBGLOGX1 ZESTAW MINI GASTRIC BYPASS Product Usage: The Endo GIA universal and Endo GI recall (Z-1848-2018)COVIDIEN MEDTRONIC2018-05-16
(1)BOX PST01199 BARIATRIC TRISTAPLE (Item Number: PST01199) (2) BOX PST03403 ALTERNATIVE A recall (Z-1849-2018)COVIDIEN MEDTRONIC2018-05-16
MGBX ZESTAW GB LS X1 Product Usage: The Endo GIA universal and Endo GIA universal XL stapl recall (Z-1850-2018)COVIDIEN MEDTRONIC2018-05-16
BOX PST03533 KIT APP STAPLER Product Usage: The Endo GIA universal and Endo GIA universal recall (Z-1852-2018)COVIDIEN MEDTRONIC2018-05-16
BOX PST03699 KIT APP MED ALTERNATIV STAP Product Usage: The Endo GIA universal and Endo GI recall (Z-1854-2018)COVIDIEN MEDTRONIC2018-05-16
(1)BOX PST04089 SLEEVE AIWA CLINIC Item Number:PST04089 SLEEVE AIWA CLINIC (2)BOX PST04090 recall (Z-1855-2018)COVIDIEN MEDTRONIC2018-05-16
SLEEVEGK1 ZESTAW DO ZABIEGOW SLEEVEX1 Product Usage: The Endo GIA universal and Endo GIA u recall (Z-1858-2018)COVIDIEN MEDTRONIC2018-05-16
(1)BOX SLEEVEGK3 (2) BOX SLEEVEGK4 SLEEVE GASTRECTOMY (3)BOX SLEEVEJAWI SLEEVE GASTRECTOMY recall (Z-1859-2018)COVIDIEN MEDTRONIC2018-05-16
BOX TGGLOGOWX1 DO TOTAL GASTRECTOMIII Product Usage: The Endo GIA universal and Endo GIA u recall (Z-1862-2018)COVIDIEN MEDTRONIC2018-05-16
BOX VATS1SCDX DO ZABIEGOW VATS Product Usage: The Endo GIA universal and Endo GIA universa recall (Z-1863-2018)COVIDIEN MEDTRONIC2018-05-16
BOX VMIN ZESTAW DO VATS PODSTAWOWY Product Usage: The Endo GIA universal and Endo GIA univ recall (Z-1865-2018)COVIDIEN MEDTRONIC2018-05-16
BOX VWR ZESTAW DO VATS KLIN Product Usage: The Endo GIA universal and Endo GIA universal X recall (Z-1866-2018)COVIDIEN MEDTRONIC2018-05-16
Endo GIA Auto Suture Universal Articulating Loading Unit for use in abdominal, gynecologic recall (Z-0636-2018)Covidien LLC2018-02-16
Covidien Endo GIA Ultra Universal 12 mm Short Stapler Handle Ref: EGIAUSHORT Product Usage recall (Z-0819-2016)Medtronic2016-02-18
Covidien Endo GIA Ultra Universal Standard Stapler Handle Ref: EGIAUSTND Product Usage: Th recall (Z-0820-2016)Medtronic2016-02-18
Covidien Endo GIA Ultra Universal 12 mm XL Stapler Handle Ref: EGIAUXL Product Usage: The recall (Z-0821-2016)Medtronic2016-02-18
Best Practice Kits containing certain production lots of Endo GIA Ultra Universal Stapler recall (Z-0822-2016)Medtronic2016-02-18
Covidien Endo GIA AutoSuture Universal Loading Unit, 30mm-2.0mm Product Code: 030450 Appli recall (Z-1063-2013)Covidien LP2013-04-05