FDA product code GEI: Electrosurgical, Cutting & Coagulation & Accessories
GEI is the FDA product code for electrosurgical, cutting & coagulation & accessories. It is a Class II device, regulated under 21 CFR 878.4400 and reviewed by the General and Plastic Surgery panel. FDA has cleared 2,319 510(k) submissions under GEI, 273 in the last five years, from 756 different applicants. The average 510(k) review took 111 days (median 84); 159 days on average over the last three years. FDA has posted 644 recalls for GEI devices, 176 initiated in the last five years.
Definition
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Classification
| Field | Value |
|---|---|
| Device name | Electrosurgical, Cutting & Coagulation & Accessories |
| Device class | Class II |
| Regulation | 21 CFR 878.4400 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for GEI
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 52 | 96 |
| 2018 | 47 | 124 |
| 2019 | 48 | 116 |
| 2020 | 59 | 147 |
| 2021 | 46 | 179 |
| 2022 | 55 | 198 |
| 2023 | 65 | 138 |
| 2024 | 59 | 161 |
| 2025 | 52 | 145 |
| 2026 | 42 | 170 |
Compare with all 510(k) review times · Search every GEI clearance
Top GEI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Arthrocare Corp. | 64 | 2010-05-13 |
| Valleylab, Inc. | 60 | 2003-05-29 |
| Conmedcorp | 43 | 2010-11-24 |
| Megadyne Medical Products, Inc. | 32 | 2024-07-12 |
| Aaron Medical Industries | 27 | 2006-10-05 |
751 more applicants have GEI clearances. See the full list in Caduvo.
Most recent GEI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K254196 | Ethicon Endo-Surgery, LLC | HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136) | 2026-09-17 | 268 |
| K261959 | Stryker Instruments | Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Rocker Switch (0703-047-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Rocker Switch, Bulk Non-Sterile (0703-047-102) | 2026-09-17 | 98 |
| K261070 | Covidien, LLC | LigaSure RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated | 2026-09-15 | 167 |
| K254185 | Jeisys Medical Incorporated | Potenza Prime | 2026-09-11 | 262 |
| K262364 | Ellian Corp | Ellian Enigma RF Device | 2026-09-02 | 54 |
Recalls for GEI devices
644 product recalls in 253 recall events; 176 initiated in the last five years and 176 still open. Most recent: 2026-08-18.
| Year | Recalls |
|---|---|
| 2017 | 20 |
| 2018 | 20 |
| 2019 | 26 |
| 2020 | 10 |
| 2021 | 14 |
| 2022 | 56 |
| 2023 | 42 |
| 2024 | 46 |
| 2025 | 16 |
| 2026 | 15 |
Frequently asked questions
What is FDA product code GEI?
GEI is the FDA product code for electrosurgical, cutting & coagulation & accessories. It is a Class II device, regulated under 21 CFR 878.4400 and reviewed by the General and Plastic Surgery panel.
What device class is GEI?
Class II, regulation 21 CFR 878.4400. Typical premarket route: 510(k).
How long does a 510(k) take for product code GEI?
Across 2,319 cleared submissions the average was 111 days from receipt to decision (median 84).
Which companies have the most GEI clearances?
Arthrocare Corp. (64); Valleylab, Inc. (60); Conmedcorp (43); Megadyne Medical Products, Inc. (32); Aaron Medical Industries (27).
Have GEI devices been recalled?
Yes: 644 product recalls across 253 recall events; the most recent began 2026-08-18.
Next steps
- Run an FDA pathway report with predicate devices for product code GEI
- Run a recall and safety report across every GEI manufacturer
- Watch product code GEI 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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