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)
Top companies in GDW
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 7, 2018 | K180175 | SignalMark Lung Biopsy Site Marker View Point Medical, Inc. | GDW |
| Nov 28, 2018 | K182380 | AEON Endoscopic Stapler Lexington Medical, Inc. | GDW |
| Sep 18, 2018 | K181653 | Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed Ethicon Endo-Surgery, LLC | GDW |
| Sep 18, 2018 | K181620 | Endoscopic Linear Cutting Staplers and Loading Units for Single Use Ezisurg (Suzhou) Medical Co., Ltd., CN | GDW |
| Feb 20, 2018 | K173270 | Tri-Staple 2.0 Reinforced Reload Covidien | GDW |
| Feb 16, 2018 | K172361 | EEA Circular Stapler with Tri-Staple Technology Covidien, CN | GDW |
| Feb 1, 2018 | K173443 | AEON Endoscopic Stapler Lexington Medical, Inc. | GDW |
| Dec 21, 2017 | K172960 | easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM Universal Linear Cutting Stapler and Load Ezisurg Medical Co., Ltd., CN | GDW |
| Dec 5, 2017 | K172561 | Disposable Circular Stapler Changzhou Kangdi Medical Stapler Co., Ltd., CN | GDW |
| Nov 30, 2017 | K172538 | Disposable Linear Stapler, Disposable Linear Cutter Changzhou Kangdi Medical Stapler Co., Ltd., CN | GDW |
| Nov 17, 2017 | K171589 | AEON Endoscopic Stapler Lexington Medical, Inc. | GDW |
| Aug 28, 2017 | K171561 | Dextera MicroCutter 30 Blue Reload, Dextera MicroCutter 30 Curved Tip Blue Reload, Dextera MicroCutter 30 White Reload, Dextera Surgical, Inc. | GDW |
| Jul 14, 2017 | K162707 | Single Use Circular Stapler, Single Use Hemorrhoidal Circular Stapler, Single Patient Use Linear Stapler and Reload, Sin Golden Stapler Surgical Co., Ltd., CN | GDW |
| May 31, 2017 | K170278 | OptiFix AT Absorbable Fixation System with Articulating Technology - 30 Fasteners, OptiFix AT Absorbable Fixation System C.R. Bard, Inc. | GDW |
| Apr 18, 2017 | K163523 | ECHELON CIRCULAR Powered Stapler Ethicon Endo-Surgery, LLC | GDW |
| Apr 11, 2017 | K163698 | OptiFix Open Absorbable Fixation System - 20 absorbable fasteners C.R. Bard, Inc. | GDW |
| Mar 3, 2017 | K162947 | Disposable End-to-end Anastomosis Circular Stapler; Universal Endoscopic Linear Cutting Stapler and Single Use Loading U Chongqing Qmi Surgical Co., Ltd., CN | GDW |
| Mar 2, 2017 | K170348 | Signia Four-Bay Smart Charger (to be used with Signia Stapler) Covidien | GDW |
| Feb 9, 2017 | K162710 | Single Use Circular Stapler, Single Use Hemorrhodial Circular Stapler, Single Patient Use Linear Stapler and Reload, Sin Tgs Medical Co., Ltd., CN | GDW |
| Jan 5, 2017 | K163454 | ECHELON FLEX 45mm Powered Plus Articulating Endoscopic Linear Cutters, ECHELON ENDOPATH Endoscopic Linear Cutter Reloads Ethicon Endo-Surgery, LLC | GDW |
| Dec 12, 2016 | K160969 | ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting Stapler Shinemed, LLC | GDW |
| Dec 5, 2016 | K163098 | Tri-Staple 2.0 Intelligent Cartridge Covidien, LLC | GDW |
| Dec 5, 2016 | K161757 | Single Use Curved Cutters, Single Use Circular Staplers, Single Use Linear Cutters and Reloads, Single Use Endoscopic Li Victor Medical Instruments Co., Ltd., CN | GDW |
| Nov 17, 2016 | K161905 | Disposable Circular Stapler for Hemorrhoids, Disposable Circular Stapler, Disposable Linear Stapler, Disposable Endoscop Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd, CN | GDW |
| Nov 14, 2016 | K162252 | FasTouch Fixation System Via Surgical , Ltd., IL | GDW |
| Jul 20, 2016 | K161137 | Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip Reload Cardica, Inc. | GDW |
| May 31, 2016 | K160900 | CapSure Fixation System - Straight 5mm x 37 cm 30 Permanent fasteners, CapSure Fixation System - Straight 5mm x 37 cm C.R. Bard, Inc. | GDW |
| Apr 26, 2016 | K160176 | Signia Stapler Covidien | GDW |
| Mar 24, 2016 | K153202 | iMESH Tacker Thd Lap, IL | GDW |
| Mar 22, 2016 | K160521 | ECHELON FLEX 60 Powered Plus Compact Articulating Endoscopic Linear Cutter, 280mm Ethicon Endo-Surgery, LLC | GDW |
| Jan 15, 2016 | K151081 | MicroCutter XCHANGE 30 Stapler, MicroCutter XCHANGE 30 Blue Cartridge, MicroCutter XCHANGE 30 White Cartridge Cardica, Inc. | GDW |
| Nov 12, 2015 | K152618 | PANTHER Cutter Stapler B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd., CN | GDW |
| Jul 17, 2015 | K151659 | ReliaTack Articulating Reloadable Fixation Device with Deep Purchase Reloadable Tacks Covidien, LLC | GDW |
| Jun 11, 2015 | K142577 | PANTHER Endo Linear Cutter Staplers with Single Use Loading Units B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd., CN | GDW |
| May 29, 2015 | K151163 | Signia Loading Unit, Tri-Staple 2.0 Cartridge Covidien, LLC | GDW |
| May 18, 2015 | K150026 | Endopath ETS-Flex45 Endoscopic Articulating Linear Cutter, Endopath ETS-Flex45 No-Knife Articulating Linear Stapler Ethicon Endo-Surgery, LLC, PR | GDW |
| Mar 12, 2015 | K142873 | OptiFix Fixation System - Straight 5mm X 39 cm - 30 absorbable fasteners, OptiFix Fixation System - Straight 5mm x 39 cm C.R. Bard, Inc. | GDW |
| Mar 9, 2015 | K142808 | CapSure Fixation System-Straight 5mm x 37 cm-30 Permanent fasteners, CapSure Fixation System-Straight 5mm x 37 cm-15 Per C.R. Bard, Inc. | GDW |
| Jan 29, 2015 | K143129 | easyEndo Linear Cutting Stapler and Loading Unit for Single Use(Stapler;Loading Unit) Ezisurg Medical Co., Ltd., CN | GDW |
| Nov 24, 2014 | K141952 | ECHELON FLEX POWERED VASCULAR STAPLER WITH ADVANCED PLACEMENT TIP, ENDOPATH ECHELON VASCULAR WHITE RELOADS FOR ADVANCED Ethicon Endo-Surgery, Inc. | GDW |
| Sep 26, 2014 | K141097 | CSC SERIES INTRALUMINAL STAPLER FOR SINGLE USE Touchstone International Medical Science Co., Ltd., CN | GDW |
| Jul 25, 2014 | K141367 | LS SERIES LINEAR STAPLER AND RELOADS, CLC SERIES CURVED LINEAR CUTTER AND RELOADS, LC SERIES LINEAR CUTTER AND RELOADS Touchstone International Medical Science Co., Ltd., CN | GDW |
| Apr 22, 2014 | K140560 | ECHELON FLEX POWERED PLUS ARTICULATING ENDOSCOPIC LINEAR CUTTER, 60MM, STANDARD, ECHELON FLEX POWERED PLUS ARTICULATING Ethicon Endo-Surgery, LLC | GDW |
| Apr 9, 2014 | K140609 | RELIATACK ARTICULATING RELOADABLE FIXATION DEVICE WITH STANDARD PURCHASE ABSORBLE TACKS Covidien | GDW |
| Apr 9, 2014 | K131563 | SUBQ IT! BIOABSORBABLE SKIN CLOSURE SYSTEM Opus Ksd, Inc. | GDW |
| Mar 14, 2014 | K132698 | FASTOUCH FIXATION SYSTEM Via Surgical , Ltd. | GDW |
| Feb 25, 2014 | K140118 | MICROCUTTER XCHANGE 30 STAPLER, MICROCUTTER XCHANGE 30 BLUE CARTRIDGE Cardica, Inc. | GDW |
| Feb 19, 2014 | K140170 | MICROCUTTER XCHANGE 30 STAPLER, MICROCUTTER XCHANGE 30 WHITE CARTRIDGE Cardica, Inc. | GDW |
| Feb 11, 2014 | K132472 | JUSTRIGHT 5MM STAPLER, JUSTRIGHT 5MM RELOAD Justright Surgical, LLC | GDW |
| Jan 22, 2014 | K133938 | ENDO GIA REINFORCED RELOAD WITH TRI-STAPLE TECHNOLOGY Covidien | GDW |
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