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)
Top companies in GDW
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | K111825 |
| 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 | K111825 |
| 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 | K111825 |
| 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 | K111825 |
| 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 | K111825 |
| 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 | K111825 |
| 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 | K111825 |
| 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 | K111825 |
| 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 | K111825 |
| 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 | K111825 |
| 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 | K111825 |
| Apr 23, 2018 | Intuitive Surgical, Inc. da Vinci Xi EndoWrist Stapler 45 Reload Green, Model
48445G-03, 12 reloads/box. Terminated |
GDW | None listed |
| Apr 23, 2018 | Intuitive Surgical, Inc. da Vinci Xi EndoWrist Stapler 45 Reload Blue, Model
48645B-03, 12 reloads/box. Terminated |
GDW | K140553 |
| Apr 9, 2018 | Covidien LLC EEA" Hemorrhoid and Prolapse Stapler Set with DST Series" Technology 4.8MM, Product Number HEM3348, GTIN Number 1 - 10884521047563, GTIN Number 2 - 20884521047560
Product Usage:
The EEA Hemorrhoid a Terminated |
GDW | K083781 |
| Apr 9, 2018 | Covidien LLC EEA" Hemorrhoid and Prolapse Stapler Set with DST Series" Technology 3.5MM, Product Number HEM3335, GTIN Number 1 - 10884521047518, GTIN Number 2 - 20884521047515
Product Usage:
The EEA Hemorrhoid a Terminated |
GDW | K083781 |
| 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 | K111825 |
| Dec 13, 2017 | Covidien LLC Signia" Power Handle (SIGPHANDLE, SIGNVAL1 and SIGVAL20 - Kits)
The Signia" Power Handle, when used with Endo GIA" single-use reloads and Endo GIA" single-use reloads with Tri-Staple" Technology, has Terminated |
GDW | K160176 |
| Oct 23, 2017 | Ethicon Endo-Surgery Inc Disposable Curved Circular Staplers
Product Usage:
Staplers have application throughout the alimentary tract for end-to-end, end-to-side, and side-to-side anastomoses. Terminated |
GDW | K983536 |
| Sep 15, 2017 | Covidien LLC Endo GIA" Radial Reload with Tri-Staple" Technology
The Endo GIA radial reloads with Tri-Staple Technology have application in open or minimally invasive general abdominal, gynecologic and thoracic Terminated |
GDW | K132493 |
| Mar 31, 2017 | Ethicon Endo-Surgery Inc Endopath ETS-FLEX Endoscopic Articulating Linear Cutter, VASCULAR/THIN 35MM Terminated |
GDW | K111111 |
| Oct 20, 2016 | Ethicon Endo-Surgery Inc Endoscopic Articulating Linear Cutter, 38ATW35. VASCULAR/THIN 35MM
The ENDOPATH ETS-Flex Endoscopic Articulating Linear Cutter has application in general, gynecologic, urologic, and thoracic surgery f Terminated |
GDW | K111111 |
| Oct 20, 2016 | Ethicon Endo-Surgery Inc Endoscopic Articulating Linear Cutter, ATB35. Standard 35 MM.
The ENDOPATH ETS-Flex Endoscopic Articulating Linear Cutter has application in general, gynecologic, urologic, and thoracic surgery for tr Terminated |
GDW | K111111 |
| 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 | K111825 |
| 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 | K111825 |
| 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 | K111825 |
| 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 | K111825 |
| Dec 24, 2015 | Cardica, Inc. MicroCutter Xchange 30 Blue Curved Tip Cartridge. Model Number: FG-025321;
The MicroCutter XCHANGE 30 Blue Cartridge and MicroCutter XCHANGE 30 Blue Curved Tip Cartridge contain 316L stainless steel s Terminated |
GDW | K140118 K140170 |
| Dec 24, 2015 | Cardica, Inc. MicroCutter Xchange 30 Blue Cartridge, FG-025320;
The MicroCutter XCHANGE 30 Blue Cartridge and MicroCutter XCHANGE 30 Blue Curved Tip Cartridge contain 316L stainless steel staples. The cartridges ar Terminated |
GDW | K132581 K140118 +1 |
| Jul 24, 2015 | EXP Pharmaceutical Services Corp Medical Device Exchange SECURESTRAP 5mm Absorbable Strap Fixation Device;
Pouch, Tyvek/Mylar, Sterile, Single Use Only;
OEM Catalog number STRAP25;
EXP (repackager), Ethicon (OEM)
Strap, implantable Terminated |
GDW | None listed |
| Jul 24, 2015 | EXP Pharmaceutical Services Corp Medical Device Exchange ETS FLEX 45 ENDOSCOPIC ARTICULATING
LINEAR CUTTER, 45MM STAPLE;
Pouch, Tyvek/Mylar, Sterile, Single Use Only;
OEM Catalog number ATS45;
EXP (repackager), Ethicon (OEM)
Impla Terminated |
GDW | None listed |
| Jul 24, 2015 | EXP Pharmaceutical Services Corp Medical Device Exchange -SYSTEM, TACKER SKIN 5MM;
Pouch, Tyvek/Mylar, Sterile, Single Use Only;
OEM Catalog number 6206;
EXP (repackager), Covidien (OEM)
Implantable Staple Terminated |
GDW | None listed |
| Jul 2, 2015 | Justright Surgical, LLC JustRight 5mm Reload, JR-REL25-2.0 Reload is packaged in cases of 12., placed in a tray and sealed with a Tyvek lid.
Product Usage:
The JustRight 5mm Stapler is intended for use in abdominal, gyneco Terminated |
GDW | None listed |
| Jul 2, 2015 | Justright Surgical, LLC JustRight 5mm Stapler, JR-ST25-2.0 Stapler is packaged in cases of 6, placed in a tray and sealed with a Tyvek lid.
Product Usage:
The JustRight 5mm Stapler is intended for use in abdominal, gynecol Terminated |
GDW | None listed |
| May 21, 2015 | Ethicon Endo-Surgery Inc ENDOPATH ECHELON" Vascular White Reload for Advanced Placement Tip,
Product Usage:
The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic an Terminated |
GDW | K141952 |
| Apr 29, 2015 | Incisive Surgical Inc Insorb Subcuticular Skin Stapler. INSORB staples are made from an absorbable copolymer which is a synthetic polyester derived from lactic and glycolic acids. It is chemically similar to other surgic Terminated |
GDW | K024117 K033602 +3 |
| Apr 23, 2015 | Laax, Inc. TIGERPAW System II,
Part number C-TP-1509 (9 connector)
The TigerPaw System II is an implantable occlusion Fastener to be placed on the Ostium of the Left Atrial Appendage (LAA). Terminated |
GDW | K111064 |
| Apr 23, 2015 | Laax, Inc. TIGERPAW System II,
Part number C-TP-1507 (7 connector)
The TigerPaw System II is an implantable occlusion Fastener to be placed on the Ostium of the Left Atrial Appendage (LAA). Terminated |
GDW | K111064 |
| Sep 23, 2014 | Justright Surgical, LLC Justright Surgical, JustRight 5mm Reload, REFJR-REL25-2.0, Sterile, EO, Rx Only
It is a replacement cartridge used when more than one firing is required during a surgery. Terminated |
GDW | K132472 |
| Sep 23, 2014 | Justright Surgical, LLC Justright Surgical, JustRight 5mm Stapler, REF JR-ST25-2.0, Sterile, EO, Rx Only, JR-ST25-2.0 product is packaged in cases of 6.
The JustRight 5mm Stapler is intended for use in abdominal, gynecologi Terminated |
GDW | K132472 |
| Jun 11, 2013 | Ethicon Endo-Surgery Inc ECHELON 60mm Endoscopic Linear Cutter Reloads Black in Flexible Blister pack with Tyvek lid.
The ECHELON and ECHELON FLEX families of Endoscopic Linear Cutters (articulating and straight) are sterile Terminated |
GDW | K112056 |
| 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 | K111825 |
| Oct 13, 2012 | Ethicon Endo-Surgery Inc Hemorrhoidal Circular Stapler and Accessories 33mm
Product Usage:
The PROXIMATE HCS Hemorrhoidal Circular Staplers, (PPH01 and PPH03), and accessories have application for general surgical tre Terminated |
GDW | K030411 K030925 +2 |
| Sep 21, 2012 | Covidien LP Covidien Duet TRS 60 4.8 mm Universal Articulating Single Use Loading Unit.
Product Code: DUET6048A.
Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Terminated |
GDW | K080898 |
| Sep 21, 2012 | Covidien LP Covidien Duet TRS 60 4.8 mm Universal Straight Single Use Loading Unit.
Product Code: DUET6048.
Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet Terminated |
GDW | K080898 |
| Sep 21, 2012 | Covidien LP Covidien Duet TRS 60 3.5 mm Universal Articulating Single Use Loading Unit.
Product Code: DUET6035A.
Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Terminated |
GDW | K080898 |
| Sep 21, 2012 | Covidien LP Covidien Duet TRS 60 3.5 mm Universal Straight Single Use Loading Unit
Product Code: DUET6035.
Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet T Terminated |
GDW | K080898 |
| Sep 21, 2012 | Covidien LP Covidien Duet TRS 45 4.8 mm Universal Articulating Single Use Loading Unit.
Product Code: DUET4548A.
Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Terminated |
GDW | K080898 |
| Sep 21, 2012 | Covidien LP Covidien Duet TRS 45 4.8 mm Universal Straight Single Use Loading Unit.
Product Code: DUET4548.
Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet Terminated |
GDW | K080898 |
| Sep 21, 2012 | Covidien LP Covidien Duet TRS 45 3.5 mm Universal Articulating Single Use Loading Unit.
Product Code: DUET4535A.
Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Terminated |
GDW | K080898 |
| Sep 21, 2012 | Covidien LP Covidien Duet TRS 45 3.5 mm Universal Straight Single Use Loading Unit.
Product Code: DUET4535.
Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet Terminated |
GDW | K080898 |
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