Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4750](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4750) → GDW — Staple, Implantable # GDW · Staple, Implantable _General, Plastic Surgery · 21 CFR 878.4750 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDW ## Overview - **Product Code:** GDW - **Device Name:** Staple, Implantable - **Regulation:** [21 CFR 878.4750](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4750) - **Device Class:** 2 - **Review Panel:** [General, Plastic Surgery](/submissions/SU) - **Implant:** yes ## Identification An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable. ## Classification Rationale Class II. ## Recent Cleared Devices (20 of 282) Showing 20 most recent of 282 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K253657](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDW/K253657.md) | Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™ Technology; Endo GIA™ Gray Articulating Reloads; Signia™ Small Diameter Reloads | Covidien (Part of Medtronic) | Apr 10, 2026 | SESE | | [K252739](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDW/K252739.md) | ETHICON™ 4000 45mm Compact Stapler (EC3DT45C); ETHICON™ 4000 45mm Standard Stapler (EC3DT45S); ETHICON™ 4000 45mm Long Stapler (EC3DT45L); ETHICON™ 3D 45mm White Reload (ER45W); ETHICON™ 3D 45mm Blue Reload (ER45B); ETHICON™ 3D 45mm Green Reload (ER45G); ETHICON™ 3D 45mm Black Reload (ER45T) | Ethicon Endo-Surgery, LLC | Dec 17, 2025 | SESE | | [K250835](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDW/K250835.md) | ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler (EC3D60S); ETHICON 4000 60mm Long Stapler (EC3D60L); ETHICON 3D 60mm White Reload (ER60W); ETHICON 3D 60mm Blue Reload (ER60B); ETHICON 3D 60mm Green Reload (ER60G); ETHICON 3D 60mm Black Reload (ER60T) | Ethicon Endo-Surgery, LLC | May 14, 2025 | SESE | | [K243276](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDW/K243276.md) | ECHELON LINEAR™ Stapler 30mm Stapler (GTX30); ECHELON LINEAR™ Stapler 60mm Stapler (GTX60); ECHELON LINEAR™ Stapler 90mm Stapler (GTX90); ECHELON LINEAR™ Stapler 3D 30mm Blue Reload (GTXR30B); ECHELON LINEAR™ Stapler 3D 30mm Green Reload (GTXR30G); ECHELON LINEAR™ Stapler 3D 60mm Blue Reload (GTXR60B); ECHELON LINEAR™ Stapler 3D 60mm Green Reload (GTXR60G); ECHELON LINEAR™ Stapler 3D 90mm Blue Reload (GTXR90B); ECHELON LINEAR™ Stapler 3D 90mm Green Reload (GTXR90G) | Ethicon Endo-Surgery, LLC | Feb 25, 2025 | SESE | | [K241630](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDW/K241630.md) | ECHELON 4000 60mm Compact Stapler (EC3D60C); ECHELON 4000 60mm Standard Stapler (EC3D60S); ECHELON 4000 60mm Long Stapler (EC3D60L); ECHELON 3D 60mm White Reload (ER60W); ECHELON 3D 60mm Blue Reload (ER60B); ECHELON 3D 60mm Green Reload (ER60G); ECHELON 3D 60mm Black Reload (ER60T) | Ethicon Endo-Surgery, LLC | Oct 28, 2024 | SESE | | [K242679](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDW/K242679.md) | Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (30mm series); Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (45mm series); Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (60mm series) | Fengh Medical Co., Ltd. | Oct 4, 2024 | SESE | | [K222487](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDW/K222487.md) | Anika Tissue Tack Fixation System | Anika Therapeutics, Inc. | May 8, 2023 | SESE | | [K222210](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDW/K222210.md) | AEON Endoscopic Stapler | Lexington Medical, Inc. | Apr 21, 2023 | SESE | | [K223760](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDW/K223760.md) | ECHELON LINEAR™ 60 mm Cutter (GLC60);ECHELON LINEAR™ 80mm Cutter (GLC80);ECHELON LINEAR™ 100 mm Cutter (GLC100);ECHELON LINEAR™ Cutters 60mm Blue Reload (GLCR60B);ECHELON LINEAR™ Cutters 60mm Green Reload (GLCR60G);ECHELON LINEAR™ Cutters 80mm Blue Reload (GLCR80B);ECHELON LINEAR™ Cutters 80mm Green Reload (GLCR80G);ECHELON LINEAR™ Cutters 100mm Blue Reload (GLCR100B);ECHELON LINEAR™ Cutters 100mm Green Reload (GLCR100G) | Ethicon Endo-Surgery | Mar 15, 2023 | SESE | | [K211197](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDW/K211197.md) | Disposable Endoscopic Cutter Stapler and Cartridge | Changzhou Waston Medical Appliance Co., Ltd. | Jan 19, 2023 | SESE | | [K221771](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDW/K221771.md) | EEA Circular Stapler with Tri-Staple Technology | Covidien | Nov 30, 2022 | SESE | | [K222641](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDW/K222641.md) | Signia™ Small Diameter Reloads Including Regular (Round) Tip Version | Covidien | Nov 29, 2022 | SESE | | [K221003](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDW/K221003.md) | Autosuture EEA Stapler / circular stapler with DST Series Technology / EEA Autosuture Circular Stapler with DST Series Technology / DST Series EEA Stapler / DST EEA | Covidien | Sep 30, 2022 | SESE | | [K221013](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDW/K221013.md) | GIA Auto Suture Stapler with DST Series Technology | Covidien | May 5, 2022 | SESE | | [K221006](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDW/K221006.md) | GIA Stapler with Tri-Staple Technology | Covidien | Apr 29, 2022 | SESE | | [K221005](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDW/K221005.md) | EEA Circular Stapler with Tri-Staple Technology | Covidien | Apr 29, 2022 | SESE | | [K211811](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDW/K211811.md) | Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers, Disposable Circular Staplers | Wuxi Beien Surgery Device Co., Ltd. | Mar 3, 2022 | SESE | | [K211458](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDW/K211458.md) | Disposable Anorectal Staplers, Disposable Intraluminal Staplers, Disposable Linear Cutting Staplers, Disposable Endoscopic Cutting Staplers | Ningbo Verykind Medical Device Co., Ltd. | Dec 30, 2021 | SESE | | [K201934](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDW/K201934.md) | Surgimatix Absorbable Fixation System | Surgimatix, Inc. | Oct 1, 2021 | SESE | | [K210909](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDW/K210909.md) | easyEndo Lite Linear Cutting Stapler and Loading Unit for Single Use | Ezisurg Medical Co., Ltd. | Jun 24, 2021 | SESE | ## Top Applicants - United States Surgical, A Division of Tyco Healthc — 28 clearances - Ethicon Endo-Surgery, LLC — 26 clearances - Covidien — 22 clearances - Power Medical Interventions, Inc. — 22 clearances - Ethicon Endo-Surgery, Inc. — 16 clearances --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDW](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDW) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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