ClearanceBrief
Panels › General, Plastic Surgery › Product code GDW · Class 2

Staple, Implantable

Regulation 878.4750

4510(k)s in 12 months (284 all time)
0recalls 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)
Apr 11, 2019Ethicon Endo-Surgery Inc
Curved Intraluminal Staplers, 33 mm diameter, Model CDH33A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrumen
Completed
GDWK983536
Apr 11, 2019Ethicon Endo-Surgery Inc
Curved Intraluminal Staplers, 29 mm diameter, Model CDH29A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrumen
Completed
GDWK983536
Apr 11, 2019Ethicon Endo-Surgery Inc
Curved Intraluminal Staplers, 25 mm diameter, Model CDH25A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrumen
Completed
GDWK983536
Apr 11, 2019Ethicon Endo-Surgery Inc
Curved Intraluminal Staplers, 21 mm diameter, Model CDH21A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrumen
Completed
GDWK983536
Dec 7, 2018Ethicon Endo-Surgery Inc
PROXIMATE PPH Hemorrhoidal Circular Stapler Product Code:PPH03 PPH03: The PROXIMATE PPH Hemorrhoidal Circular Stapler and Accessories have application throughout the anal canal to perform surgical tr
Terminated
GDWK051301
Dec 7, 2018Ethicon Endo-Surgery Inc
PROXIMATE HCS Hemorrhoidal Circular Stapler Product Code: PPH01 PPH01: The PROXIMATE HCS Hemorrhoidal Circular Stapler and Accessories have application for general surgical treatment of anorectal wa
Terminated
GDWK030925
Aug 29, 2018Incisive Surgical Inc
INSORB SUBCUTICULAR SKIN STAPLER, REF 2030
Terminated
GDWK120373
Jul 19, 2018COVIDIEN MEDTRONIC
Tri-Staple 2.0 Curved Tip Intelligent Reload for use with Signia stapling system , Item Code EGIA30CTAV
Open, Classified
GDWNone listed
Jul 19, 2018COVIDIEN MEDTRONIC
Tri-Staple 2.0 Curved Tip Intelligent Reload for use with Signia stapling system 45 mm Vascular/Medium, Item Code SIG45ACTAVM
Open, Classified
GDWNone listed
Jul 19, 2018COVIDIEN MEDTRONIC
Tri-Staple 2.0 Curved Tip Intelligent Reload for use with Signia stapling system 30 mm Vascular/Medium, Item Code SIG30ACTAVM
Open, Classified
GDWNone listed
Jul 19, 2018COVIDIEN MEDTRONIC
Tri-Staple 2.0 Intelligent Reload for use with Signia stapling system 30 mm Medium/Thick, Item Code SIG30AMT
Open, Classified
GDWNone listed
Jul 19, 2018COVIDIEN MEDTRONIC
Endo GIA 45mm Curved Tip Articulating Vascular/Medium Reload with Tri-Staple Technology, Item Code EGIA45CTAVM
Open, Classified
GDWNone listed
Jul 19, 2018COVIDIEN MEDTRONIC
Endo GIA 45 mm Articulating Vascular/Medium Loading Unit with Tri-Staple Technology, Item Code EGIA454AVM
Open, Classified
GDWNone listed
Jul 19, 2018COVIDIEN MEDTRONIC
Endo GIA 45 mm Extra Thick Black Articulating Reload with Tri-Staple Technology, Item Code EGIA45AXT
Open, Classified
GDWNone listed
Jul 19, 2018COVIDIEN MEDTRONIC
Endo GIA 45mm Gray Articulating Vascular Reload with Tri-Staple Technology, Item Code EGIA45AV
Open, Classified
GDWNone listed
Jul 19, 2018COVIDIEN MEDTRONIC
Tri-Staple 2.0 Intelligent Reload for use with Signia stapling system 30 mm Vascular/Medium, Item Code SIG30AVM
Open, Classified
GDWNone listed
Jul 19, 2018COVIDIEN MEDTRONIC
Tri-Staple 2.0 Black Intelligent Reload for use with Signia stapling system 60 mm Extra Thick, Item Code SIG60AXT
Open, Classified
GDWNone listed
Jul 19, 2018COVIDIEN MEDTRONIC
Endo GIA 60 mm Articulating Vascular/Medium Loading Unit with Tri-Staple Technology, Item Code EGIA60AVM
Open, Classified
GDWNone listed
Jul 19, 2018COVIDIEN MEDTRONIC
Endo GIA 60 mm Extra Thick Black Articulating Reload with Tri-Staple Technology, Item Code EGIA60AXT
Open, Classified
GDWK111825
Jul 19, 2018COVIDIEN MEDTRONIC
Endo GIA 60 mm Articulating Medium/Thick Reload with Tri-StapleTechnology, Item Code EGIA60AMT
Open, Classified
GDWK111825
Jul 19, 2018COVIDIEN MEDTRONIC
Endo GIA 45 mm Articulating Medium/Thick Reload with Tri-Staple Technology, Item Code EGIA45AMT
Open, Classified
GDWK111825
May 16, 2018COVIDIEN 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
GDWK111825
May 16, 2018COVIDIEN 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
GDWK111825
May 16, 2018COVIDIEN 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
GDWK111825
May 16, 2018COVIDIEN 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
GDWK111825
May 16, 2018COVIDIEN 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
GDWK111825
May 16, 2018COVIDIEN 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
GDWK111825
May 16, 2018COVIDIEN 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
GDWK111825
May 16, 2018COVIDIEN 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
GDWK111825
May 16, 2018COVIDIEN 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
GDWK111825
May 16, 2018COVIDIEN 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
GDWK111825
May 16, 2018COVIDIEN 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
GDWK111825
May 16, 2018COVIDIEN 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
GDWK111825
May 16, 2018COVIDIEN 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
GDWK111825
May 16, 2018COVIDIEN 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
GDWK111825
May 16, 2018COVIDIEN 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
GDWK111825
May 16, 2018COVIDIEN 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
GDWK111825
May 16, 2018COVIDIEN 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
GDWK111825
May 16, 2018COVIDIEN 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
GDWK111825
May 16, 2018COVIDIEN 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
GDWK111825
May 16, 2018COVIDIEN 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
GDWK111825
May 16, 2018COVIDIEN 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
GDWK111825
May 16, 2018COVIDIEN 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
GDWK111825
May 16, 2018COVIDIEN 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
GDWK111825
May 16, 2018COVIDIEN 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
GDWK111825
May 16, 2018COVIDIEN 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
GDWK111825
May 16, 2018COVIDIEN 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
GDWK111825
May 16, 2018COVIDIEN 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
GDWK111825
May 16, 2018COVIDIEN 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
GDWK111825
May 16, 2018COVIDIEN 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
GDWK111825

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