GEI — Electrosurgical, Cutting & Coagulation & Accessories Class II
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 |
|---|---|---|---|
| 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 |
| K253918 | f care systems usa | Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St) | June 2, 2026 |
| K253803 | lumenis be | MILAN System | 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 |
| K254122 | arthrocare corporation | FLOW FLEXTEND Wand (72290039) | March 30, 2026 |
| K260255 | aventix medical | AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001) | March 27, 2026 |
| K253680 | arthrocare corporation | LYNX COBLATION Laryngeal Wand (72290254) | March 25, 2026 |
| K253750 | btl industries | BTL-785NEH | March 17, 2026 |