GDW · Staple, Implantable
General, Plastic Surgery · 21 CFR 878.4750 · Class 2
Overview
| Product Code | GDW |
|---|---|
| Device Name | Staple, Implantable |
| Regulation | 21 CFR 878.4750 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | Anika Tissue Tack Fixation System | Anika Therapeutics, Inc. | May 8, 2023 | SESE |
| K222210 | AEON Endoscopic Stapler | Lexington Medical, Inc. | Apr 21, 2023 | SESE |
| K223760 | 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 | Disposable Endoscopic Cutter Stapler and Cartridge | Changzhou Waston Medical Appliance Co., Ltd. | Jan 19, 2023 | SESE |
| K221771 | EEA Circular Stapler with Tri-Staple Technology | Covidien | Nov 30, 2022 | SESE |
| K222641 | Signia Small Diameter Reloads Including Regular (Round) Tip Version | Covidien | Nov 29, 2022 | SESE |
| K221003 | 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 | GIA Auto Suture Stapler with DST Series Technology | Covidien | May 5, 2022 | SESE |
| K221006 | GIA Stapler with Tri-Staple Technology | Covidien | Apr 29, 2022 | SESE |
| K221005 | EEA Circular Stapler with Tri-Staple Technology | Covidien | Apr 29, 2022 | SESE |
| K211811 | 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 | 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 | Surgimatix Absorbable Fixation System | Surgimatix, Inc. | Oct 1, 2021 | SESE |
| K210909 | 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
