GEI — Electrosurgical, Cutting & Coagulation & Accessories Class II
FDA product code GEI covers "Electrosurgical, Cutting & Coagulation & Accessories", a Class II medical device regulated under 21 CFR 878.4400. Submissions are reviewed by the General, Plastic Surgery panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GEI
- Device Class
- Class II
- Regulation Number
- 878.4400
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
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).
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K261959 | Stryker Instruments | Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push | Sep 17, 2026 |
| K254196 | Ethicon Endo-Surgery | HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136) | Sep 17, 2026 |
| K261070 | Covidien | LigaSure RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated | Sep 15, 2026 |
| K254185 | Jeisys Medical Incorporated | Potenza Prime | Sep 11, 2026 |
| K262364 | Ellian | Ellian Enigma RF Device | Sep 2, 2026 |
| K253859 | Viol Co | Scarlet Pro (Scarlet Pro) | Aug 27, 2026 |
| K252535 | Taiwan Surgical Corporation | Inno-Switch Laparoscopic Instruments | Aug 25, 2026 |
| K261179 | Gimmi | AlphaTriPart - Monopolar MIC Instruments | Jul 22, 2026 |
| K253504 | Classys | Volnewmer | Jul 13, 2026 |
| K254056 | Olympus Medical Systems | THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 | Jul 1, 2026 |
| K251492 | New Deantronics Taiwan | Irrigation Tubing Bipolar Cord Set | Jun 29, 2026 |
| K253484 | Cynosure Lutronic Technology Corporation | LUTRONIC GENIUS | Jun 29, 2026 |
| K260636 | Stryker Sustainability Solutions | Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating | Jun 18, 2026 |
| K253634 | Hologic | CoolSeal Generator® (CSL-200-90) | Jun 17, 2026 |
| K261833 | Neurent Medical | NEUROMARK System (NMK00301) | Jun 16, 2026 |
| K253165 | Sejong Medical Co | LAP-iX2N | Jun 9, 2026 |
| K253656 | Medtronic Sofamor Danek Usa | OsteoCool RF Ablation System; OsteoCool 2.0 RF Ablation System | Jun 5, 2026 |
| K253803 | Lumenis Be | MILAN System | Jun 2, 2026 |
| K253918 | F Care Systems Usa | Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St) | Jun 2, 2026 |
| K261202 | Entire Medical | ENTire IRE System | May 29, 2026 |