FDA product code GAG: Stapler, Surgical
GAG is the FDA product code for stapler, surgical. It is a Class II device, regulated under 21 CFR 878.4740 and reviewed by the General and Plastic Surgery panel. FDA has cleared 43 510(k) submissions under GAG, 11 in the last five years, from 22 different applicants. The average 510(k) review took 89 days (median 61); 147 days on average over the last three years. FDA has posted 10 recalls for GAG devices, 1 initiated in the last five years.
Definition
A surgical stapler for internal use is a specialized prescription device used to deliver compatible staples to internal tissues during surgery for resection, transection, and creating anastomoses.
Classification
| Field | Value |
|---|---|
| Device name | Stapler, Surgical |
| Device class | Class II |
| Regulation | 21 CFR 878.4740 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
510(k) clearances per year for GAG
| Year | Clearances | Avg. review days |
|---|---|---|
| 2022 | 1 | 142 |
| 2023 | 4 | 124 |
| 2024 | 3 | 126 |
| 2025 | 2 | 84 |
| 2026 | 1 | 230 |
Compare with all 510(k) review times · Search every GAG clearance
Top GAG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| ETHICON, Inc. | 6 | 1989-05-26 |
| Covidien | 4 | 2023-10-27 |
| Davis & Geck, Inc. | 4 | 1984-12-17 |
| Ethicon Endo-Surgery, Inc. | 3 | 1997-03-11 |
| American V. Mueller | 3 | 1986-08-18 |
17 more applicants have GAG clearances. See the full list in Caduvo.
Most recent GAG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253527 | Covidien, LLC | Tri-Staple 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple 2.0 Black Circular Reload 25mm Extra Thick (SIGCIR25XT) | 2026-07-01 | 230 |
| K251482 | Lexington Medical, Inc. | AEON Endoscopic Powered Stapler | 2025-07-11 | 58 |
| K243596 | Intuitive Surgical, Inc. | da Vinci SP SureForm 45 Staplers and Reloads (SP1098) | 2025-03-10 | 109 |
| K240881 | Covidien (Part of Medtronic) | Signia Circular Adapter (Standard Length) (SIGCIRSTND); Signia Circular Adapter XL Length (SIGCIRXL) | 2024-11-01 | 214 |
| K241629 | Ethicon Endo-Surgery, LLC | ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S); Echelon 3000 45mm Long Stapler (ECH45L); Echelon 3000 60mm Compact Stapler (ECH60C); Echelon 3000 60mm Standard Stapler (ECH60S); Echelon 3000 60mm Long Stapler (ECH60L) | 2024-07-03 | 27 |
Recalls for GAG devices
10 product recalls in 8 recall events; 1 initiated in the last five years and 3 still open. Most recent: 2022-05-13.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2019 | 2 |
| 2022 | 1 |
Frequently asked questions
What is FDA product code GAG?
GAG is the FDA product code for stapler, surgical. It is a Class II device, regulated under 21 CFR 878.4740 and reviewed by the General and Plastic Surgery panel.
What device class is GAG?
Class II, regulation 21 CFR 878.4740. Typical premarket route: 510(k).
How long does a 510(k) take for product code GAG?
Across 43 cleared submissions the average was 89 days from receipt to decision (median 61).
Which companies have the most GAG clearances?
ETHICON, Inc. (6); Covidien (4); Davis & Geck, Inc. (4); Ethicon Endo-Surgery, Inc. (3); American V. Mueller (3).
Have GAG devices been recalled?
Yes: 10 product recalls across 8 recall events; the most recent began 2022-05-13.
Next steps
- Run an FDA pathway report with predicate devices for product code GAG
- Run a recall and safety report across every GAG manufacturer
- Watch product code GAG 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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