FDA product code GDW: Staple, Implantable
GDW is the FDA product code for staple, implantable. It is a Class II device, regulated under 21 CFR 878.4750 and reviewed by the General and Plastic Surgery panel. FDA has cleared 283 510(k) submissions under GDW, 18 in the last five years, from 96 different applicants. The average 510(k) review took 95 days (median 71); 103 days on average over the last three years. FDA has posted 225 recalls for GDW devices, 11 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Staple, Implantable |
| Device class | Class II |
| Regulation | 21 CFR 878.4750 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for GDW
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 13 | 116 |
| 2018 | 7 | 143 |
| 2019 | 12 | 189 |
| 2020 | 10 | 90 |
| 2021 | 9 | 226 |
| 2022 | 7 | 110 |
| 2023 | 4 | 316 |
| 2024 | 2 | 86 |
| 2025 | 3 | 99 |
| 2026 | 2 | 125 |
Compare with all 510(k) review times · Search every GDW clearance
Top GDW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| United States Surgical, A Division of Tyco Healthc | 28 | 2007-09-28 |
| Ethicon Endo-Surgery, LLC | 27 | 2026-05-11 |
| Covidien | 22 | 2022-11-30 |
| Power Medical Interventions, Inc. | 22 | 2009-05-18 |
| Ethicon Endo-Surgery, Inc. | 16 | 2014-11-24 |
91 more applicants have GDW clearances. See the full list in Caduvo.
Most recent GDW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260196 | Ethicon Endo-Surgery, LLC | ETHICON Circular Stapler (CDH21mm); ETHICON Circular Stapler (CDH25mm); ETHICON Circular Stapler (CDH29mm); ETHICON Circular Stapler (CDH33mm); ETHICON Circular Stapler - XL Sealed (ECS21mm); ETHICON Circular Stapler - XL Sealed (ECS25mm); ETHICON Circular Stapler - XL Sealed (ECS29mm); ETHICON Circular Stapler - XL Sealed (ECS33mm) | 2026-05-11 | 109 |
| K253657 | Covidien (Part of Medtronic) | Tri-staple 2.0 Reloads; Endo GIA Reloads with Tri-Staple Technology; Endo GIA Gray Articulating Reloads; Signia Small Diameter Reloads | 2026-04-10 | 141 |
| K252739 | Ethicon Endo-Surgery, LLC | 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) | 2025-12-17 | 111 |
| K250835 | Ethicon Endo-Surgery, LLC | 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) | 2025-05-14 | 55 |
| K243276 | Ethicon Endo-Surgery, LLC | 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) | 2025-02-25 | 132 |
Recalls for GDW devices
225 product recalls in 58 recall events; 11 initiated in the last five years and 46 still open. Most recent: 2025-09-25.
| Year | Recalls |
|---|---|
| 2017 | 5 |
| 2018 | 61 |
| 2019 | 28 |
| 2020 | 12 |
| 2021 | 3 |
| 2023 | 2 |
| 2024 | 5 |
| 2025 | 4 |
Frequently asked questions
What is FDA product code GDW?
GDW is the FDA product code for staple, implantable. It is a Class II device, regulated under 21 CFR 878.4750 and reviewed by the General and Plastic Surgery panel.
What device class is GDW?
Class II, regulation 21 CFR 878.4750. Typical premarket route: 510(k).
How long does a 510(k) take for product code GDW?
Across 283 cleared submissions the average was 95 days from receipt to decision (median 71).
Which companies have the most GDW clearances?
United States Surgical, A Division of Tyco Healthc (28); Ethicon Endo-Surgery, LLC (27); Covidien (22); Power Medical Interventions, Inc. (22); Ethicon Endo-Surgery, Inc. (16).
Have GDW devices been recalled?
Yes: 225 product recalls across 58 recall events; the most recent began 2025-09-25.
Next steps
- Run an FDA pathway report with predicate devices for product code GDW
- Run a recall and safety report across every GDW manufacturer
- Watch product code GDW for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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