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 |
|---|---|---|---|
| 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 |
| K252487 | gyrus acmi | POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA) | March 2, 2026 |
| K260287 | single pass | SP Electrocautery Device (SP20) | February 24, 2026 |
| K251813 | sutter medizintechnik | CURIS II RF Generator (REF 360100-05) | February 11, 2026 |
| K251836 | shenzhen gsd technology co | Dermatrix Duo | February 6, 2026 |
| K254290 | shenzhen peninsula medical group | ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+ | January 30, 2026 |
| K254220 | soniquence | Reusable 3 Button Fingerswitch Wand | January 27, 2026 |
| K251435 | inbella medical | InbellaIgnite RF System | January 27, 2026 |
| K251254 | inmode | Ignite RF System | January 15, 2026 |
| K251996 | entire medical | ENTire IRE System | January 14, 2026 |
| K251988 | boston aesthetics | Boston iFace (Boston iFace) | January 12, 2026 |
| K253915 | erbe elektromedizin | MOVIVA® Hybrid Ablation Probe | December 18, 2025 |