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 |
|---|---|---|---|
| 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 |
| K252704 | f care systems usa | F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB, 06P | November 24, 2025 |
| K251566 | starmed co | TS-RF Generator (STS10) | November 17, 2025 |
| K252845 | venus concept | Venus Nova (FP-2001) | November 6, 2025 |
| K252740 | applied medical resources | Voyant® Open Fusion Device (EB240/Open Fusion) | November 4, 2025 |
| K252412 | applied medical resources corporation | Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator) | October 31, 2025 |
| K250275 | baylis medical technologies | PrecisePath Radiofrequency Puncture Generator and PrecisePath Footswitch | October 28, 2025 |
| K250126 | livsmed | ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M) | October 21, 2025 |
| K250852 | asterasys co | Coolfase | October 16, 2025 |
| K252367 | inbella medical | InbellaMulti System | October 15, 2025 |