GDW — Staple, Implantable Class II
FDA product code GDW covers "Staple, Implantable", a Class II medical device regulated under 21 CFR 878.4750. Submissions are reviewed by the General, Plastic Surgery panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GDW
- Device Class
- Class II
- Regulation Number
- 878.4750
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260196 | ethicon endo-surgery | ETHICON Circular Stapler (CDH21mm); ETHICON Circular Stapler (CDH25mm); ETHICO | May 11, 2026 |
| K253657 | covidien (part of medtronic) | Tri-staple 2.0 Reloads; Endo GIA Reloads with Tri-Staple Technology; Endo GIA | April 10, 2026 |
| K252739 | ethicon endo-surgery | ETHICON 4000 45mm Compact Stapler (EC3DT45C); ETHICON 4000 45mm Standard Stapl | December 17, 2025 |
| K250835 | ethicon endo-surgery | ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler | May 14, 2025 |
| K243276 | ethicon endo-surgery | ECHELON LINEAR Stapler 30mm Stapler (GTX30); ECHELON LINEAR Stapler 60mm Stapl | February 25, 2025 |
| K241630 | ethicon endo-surgery | ECHELON 4000 60mm Compact Stapler (EC3D60C); ECHELON 4000 60mm Standard Stapler | October 28, 2024 |
| K242679 | fengh medical co | Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (30mm | October 4, 2024 |
| K222487 | anika therapeutics | Anika Tissue Tack Fixation System | May 8, 2023 |
| K222210 | lexington medical | AEON Endoscopic Stapler | April 21, 2023 |
| K223760 | ethicon endo-surgery | ECHELON LINEAR 60 mm Cutter (GLC60);ECHELON LINEAR 80mm Cutter (GLC80);ECHELO | March 15, 2023 |
| K211197 | changzhou waston medical appliance co | Disposable Endoscopic Cutter Stapler and Cartridge | January 19, 2023 |
| K221771 | covidien | EEA Circular Stapler with Tri-Staple Technology | November 30, 2022 |
| K222641 | covidien | Signia Small Diameter Reloads Including Regular (Round) Tip Version | November 29, 2022 |
| K221003 | covidien | Autosuture EEA Stapler / circular stapler with DST Series Technology / EEA Autos | September 30, 2022 |
| K221013 | covidien | GIA Auto Suture Stapler with DST Series Technology | May 5, 2022 |
| K221005 | covidien | EEA Circular Stapler with Tri-Staple Technology | April 29, 2022 |
| K221006 | covidien | GIA Stapler with Tri-Staple Technology | April 29, 2022 |
| K211811 | wuxi beien surgery device co | Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter S | March 3, 2022 |
| K211458 | ningbo verykind medical device co | Disposable Anorectal Staplers, Disposable Intraluminal Staplers, Disposable Line | December 30, 2021 |
| K201934 | surgimatix | Surgimatix Absorbable Fixation System | October 1, 2021 |