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 |
|---|---|---|---|
| K253504 | classys | Volnewmer | July 13, 2026 |
| K254056 | olympus medical systems | THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 | July 1, 2026 |
| K251492 | new deantronics taiwan | Irrigation Tubing Bipolar Cord Set | June 29, 2026 |
| K253484 | cynosure lutronic technology corporation | LUTRONIC GENIUS | June 29, 2026 |
| K260636 | stryker sustainability solutions | Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating | June 18, 2026 |
| K253634 | hologic | CoolSeal Generator® (CSL-200-90) | June 17, 2026 |
| K261833 | neurent medical | NEUROMARK System (NMK00301) | June 16, 2026 |
| K253165 | sejong medical co | LAP-iX2N | June 9, 2026 |
| K253656 | medtronic sofamor danek usa | OsteoCool RF Ablation System; OsteoCool 2.0 RF Ablation System | June 5, 2026 |
| K253803 | lumenis be | MILAN System | June 2, 2026 |
| K253918 | f care systems usa | Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St) | June 2, 2026 |
| K261202 | entire medical | ENTire IRE System | May 29, 2026 |
| K252833 | starmed co | VIVA combo RF System | May 26, 2026 |
| K253134 | lagis enterprise co | LAGIS Endoscopic Instruments- Scissors (EI-330S EI-330S-T EI-330MS EI-330MS-T) | May 20, 2026 |
| K260522 | aerin medical | RhinAer+ Stylus | May 18, 2026 |
| K253917 | plasma surgical | ARION ARC System | April 10, 2026 |
| K253777 | ascblue corporation | Ascblue (8010) | April 10, 2026 |
| K260466 | zhejiang shuyou surgical instrument co | Multifunctional Operational Dissectors (Electrosurgical Pencils);Multifunctional | April 7, 2026 |
| K260397 | hironic co | SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002) | April 6, 2026 |
| K253405 | prana surgical | Prana System | April 1, 2026 |