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 |
|---|---|---|---|
| Sep 25, 2026 | K254291 | easyEndo E-Lite Single Use Powered Endoscopic Staplers; easyEndo E-Lite Single Use Powered Endoscopic Staplers with Cu Ezisurg Medical Co., Ltd., CN | GDW |
| May 11, 2026 | K260196 | ETHICON Circular Stapler (CDH21mm); ETHICON Circular Stapler (CDH25mm); ETHICON Circular Stapler (CDH29mm); ETHICON Ethicon Endo-Surgery, LLC | GDW |
| Apr 10, 2026 | K253657 | Tri-staple 2.0 Reloads; Endo GIA Reloads with Tri-Staple Technology; Endo GIA Gray Articulating Reloads; Signia Sma Covidien (Part of Medtronic) | GDW |
| Dec 17, 2025 | K252739 | ETHICON 4000 45mm Compact Stapler (EC3DT45C); ETHICON 4000 45mm Standard Stapler (EC3DT45S); ETHICON 4000 45mm Long S Ethicon Endo-Surgery, LLC | GDW |
| May 14, 2025 | K250835 | ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler (EC3D60S); ETHICON 4000 60mm Long Staple Ethicon Endo-Surgery, LLC | GDW |
| Feb 25, 2025 | K243276 | ECHELON LINEAR Stapler 30mm Stapler (GTX30); ECHELON LINEAR Stapler 60mm Stapler (GTX60); ECHELON LINEAR Stapler 90mm Ethicon Endo-Surgery, LLC | GDW |
| Oct 28, 2024 | K241630 | ECHELON 4000 60mm Compact Stapler (EC3D60C); ECHELON 4000 60mm Standard Stapler (EC3D60S); ECHELON 4000 60mm Long Staple Ethicon Endo-Surgery, LLC | GDW |
| Oct 4, 2024 | K242679 | Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (30mm series); Disposable Powered Articulatin Fengh Medical Co., Ltd., CN | GDW |
| May 8, 2023 | K222487 | Anika Tissue Tack Fixation System Anika Therapeutics, Inc. | GDW |
| Apr 21, 2023 | K222210 | AEON Endoscopic Stapler Lexington Medical, Inc. | GDW |
| Mar 15, 2023 | K223760 | ECHELON LINEAR 60 mm Cutter (GLC60);ECHELON LINEAR 80mm Cutter (GLC80);ECHELON LINEAR 100 mm Cutter (GLC100);ECHELON Ethicon Endo-Surgery | GDW |
| Jan 19, 2023 | K211197 | Disposable Endoscopic Cutter Stapler and Cartridge Changzhou Waston Medical Appliance Co., Ltd., CN | GDW |
| Nov 30, 2022 | K221771 | EEA Circular Stapler with Tri-Staple Technology Covidien, CN | GDW |
| Nov 29, 2022 | K222641 | Signia Small Diameter Reloads Including Regular (Round) Tip Version Covidien | GDW |
| Sep 30, 2022 | K221003 | Autosuture EEA Stapler / circular stapler with DST Series Technology / EEA Autosuture Circular Stapler with DST Series T Covidien | GDW |
| May 5, 2022 | K221013 | GIA Auto Suture Stapler with DST Series Technology Covidien | GDW |
| Apr 29, 2022 | K221006 | GIA Stapler with Tri-Staple Technology Covidien, CN | GDW |
| Apr 29, 2022 | K221005 | EEA Circular Stapler with Tri-Staple Technology Covidien, CN | GDW |
| Mar 3, 2022 | K211811 | Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staple Wuxi Beien Surgery Device Co., Ltd., CN | GDW |
| Dec 30, 2021 | K211458 | Disposable Anorectal Staplers, Disposable Intraluminal Staplers, Disposable Linear Cutting Staplers, Disposable Endoscop Ningbo Verykind Medical Device Co., Ltd., CN | GDW |
| Oct 1, 2021 | K201934 | Surgimatix Absorbable Fixation System Surgimatix, Inc. | GDW |
| Jun 24, 2021 | K210909 | easyEndo Lite Linear Cutting Stapler and Loading Unit for Single Use Ezisurg Medical Co., Ltd., CN | GDW |
| May 27, 2021 | K201639 | Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler and Reloads, Disposable Linear Cu Beijing Biosis Healing Biolog Ical Technology Co., Ltd., CN | GDW |
| May 18, 2021 | K202709 | Disposable Powered Endoscopic Linear Cutting Staplers and Cartridges Ningbo Verykind Medical Device Co., Ltd., CN | GDW |
| Apr 28, 2021 | K210278 | Titan SGS Standard Bariatrics | GDW |
| Feb 5, 2021 | K200320 | Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular Stapler, Mirus Linear Stapler and Re M/s. Meril Endo Surgery Private Limited., IN | GDW |
| Jan 21, 2021 | K202507 | EEA Circular Stapler with Tri-Staple Technology Covidien, CN | GDW |
| Jan 7, 2021 | K203117 | TissueTak device Via Surgical , Ltd., IL | GDW |
| Dec 14, 2020 | K202467 | Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads Fengh Medical Co., Ltd., CN | GDW |
| Dec 7, 2020 | K202701 | GIA Stapler with Tri-Staple Technology Covidien, CN | GDW |
| Oct 28, 2020 | K202864 | Tri-Staple 2.0 Reloads Covidien | GDW |
| Oct 15, 2020 | K202665 | Echelon Flex 45mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Flex 60mm Powered Plus Articulating Endos Ethicon Endo-Surgery, LLC | GDW |
| Oct 9, 2020 | K201882 | AEON Endoscopic Stapler Lexington Medical, Inc. | GDW |
| Jul 27, 2020 | K201280 | Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed Ethicon Endo-Surgery, LLC | GDW |
| Jul 17, 2020 | K201672 | Signia Stapler (with new software) Covidien | GDW |
| Jun 29, 2020 | K200420 | Echelon Contour Curved Cutter with blue reload, Echelon Contour Curved Cutter with green reload, Echelon Contour Curved Ethicon Endo-Surgery, LLC | GDW |
| Mar 13, 2020 | K192720 | GIA Stapler with Tri-Staple Technology Covidien, CN | GDW |
| Jan 23, 2020 | K192330 | EEA Circular Stapler with Tri-Staple Technology Covidien, CN | GDW |
| Dec 26, 2019 | K190884 | TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool Datascope Corp. | GDW |
| Dec 18, 2019 | K182476 | Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads Fengh Medical Co., Ltd., CN | GDW |
| Nov 22, 2019 | K190331 | Applied Medical Laparoscopic Linear Cutter Applied Medical Resources Corporation | GDW |
| Oct 17, 2019 | K192566 | Reach and CQ'ENCE Circular Staplers Reach Surgical, Inc., CN | GDW |
| Sep 4, 2019 | K191070 | Signia Small Diameter Reloads Covidien | GDW |
| Jul 16, 2019 | K191287 | OptiFix AT Absorbable Fixation System with Articulating Technology 30 Fasteners, OptiFix AT Absorbable Fixation System Davol Inc., Subsidiary of C.R. Bard | GDW |
| Apr 16, 2019 | K182217 | Linear Cutter Staplers and Loading Units for Single Use, Circular Staplers for Single Use Ezisurg (Suzhou) Medical Co., Ltd., CN | GDW |
| Mar 14, 2019 | K182475 | Signia Circular Adapters (for use with Signia Staplers), Tri-Staple 2.0 Circular Reloads (for use with Signia Circular A Covidien | GDW |
| Mar 13, 2019 | K181668 | FasTouch Absorbable Fixation System Via Surgical , Ltd., IL | GDW |
| Feb 11, 2019 | K183477 | easyPPHTM Hemorrhoidal Stapler for Single Use Ezisurg Medical Co., Ltd., CN | GDW |
| Feb 6, 2019 | K183435 | Echelon Endoscopic Linear Cutter Reloads, White, Blue, Gold, Green and Black Ethicon Endo-Surgery, LLC | GDW |
| Feb 1, 2019 | K181657 | easyLCTM Linear Cutter Staplers and Loading Units fot Single Use; easyCSTM Circular Stapler for Single Use Ezisurg Medical Co., Ltd., CN | GDW |
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