Product code GEI
- Device name
- Electrosurgical, Cutting & Coagulation & Accessories
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation number
- 878.4400
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Ineligible
- 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).
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253656 | OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation System | Medtronic Sofamor Danek USA, Inc. | 2026-06-05 |
| K253918 | Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St) | F Care Systems USA, LLC | 2026-06-02 |
| K253803 | MILAN System | Lumenis Be, Ltd. | 2026-06-02 |
| K261202 | ENTire IRE System | Entire Medical , Ltd. | 2026-05-29 |
| K252833 | VIVA combo RF System | Starmed Co., Ltd. | 2026-05-26 |
| K253134 | LAGIS Endoscopic Instruments- Scissors (EI-330S EI-330S-T EI-330MS EI-330MS-T) | Lagis Enterprise Co., Ltd. | 2026-05-20 |
| K260522 | RhinAer+ Stylus | Aerin Medical, Inc. | 2026-05-18 |
| K253917 | ARION ARC System | Plasma Surgical, Inc. | 2026-04-10 |
| K253777 | Ascblue (8010) | Ascblue Corporation | 2026-04-10 |
| K260466 | Multifunctional Operational Dissectors (Electrosurgical Pencils);Multifunctional Operational Dissectors (Disposable Electrode) | Zhejiang shuyou Surgical Instrument Co., Ltd. | 2026-04-07 |
| K260397 | SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002) | Hironic Co., Ltd. | 2026-04-06 |
| K253405 | Prana System | Prana Surgical | 2026-04-01 |
| K254122 | FLOW FLEXTEND Wand (72290039) | ArthroCare Corporation | 2026-03-30 |
| K260255 | AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001) | Aventix Medical, Inc. | 2026-03-27 |
| K253680 | LYNX COBLATION Laryngeal Wand (72290254) | ArthroCare Corporation | 2026-03-25 |
| K253750 | BTL-785NEH | BTL Industries, Inc. | 2026-03-17 |
| K252487 | POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA) | Gyrus Acmi, Inc. | 2026-03-02 |
| K260287 | SP Electrocautery Device (SP20) | Single Pass, Inc. | 2026-02-24 |
| K251813 | CURIS II RF Generator (REF 360100-05) | Sutter Medizintechnik GmbH | 2026-02-11 |
| K251836 | Dermatrix Duo | Shenzhen Gsd Technology Co., Ltd. | 2026-02-06 |
| K254290 | ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III) | Shenzhen Peninsula Medical Group | 2026-01-30 |
| K254220 | Reusable 3 Button Fingerswitch Wand | Soniquence, LLC | 2026-01-27 |
| K251435 | InbellaIgnite RF System | Inbella Medical, Inc. | 2026-01-27 |
| K251254 | Ignite RF System | InMode , Ltd. | 2026-01-15 |
| K251996 | ENTire IRE System | Entire Medical , Ltd. | 2026-01-14 |
| K251988 | Boston iFace (Boston iFace) | Boston Aesthetics, Inc. | 2026-01-12 |
| K253915 | MOVIVA® Hybrid Ablation Probe | Erbe Elektromedizin GmbH | 2025-12-18 |
| K252704 | F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB, 06Pedal1St) | F Care Systems USA, LLC | 2025-11-24 |
| K251566 | TS-RF Generator (STS10) | Starmed Co., Ltd. | 2025-11-17 |
| K252845 | Venus Nova (FP-2001) | Venus Concept, Inc. | 2025-11-06 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00198506091308 | ELMED INCORPORATED | ELMED INCORPORATED | 2026-06-09 |
| 00198506091360 | ELMED INCORPORATED | ELMED INCORPORATED | 2026-06-09 |
| 00198506091377 | ELMED INCORPORATED | ELMED INCORPORATED | 2026-06-09 |
| 00198506091384 | ELMED INCORPORATED | ELMED INCORPORATED | 2026-06-09 |
| 00198506091391 | ELMED INCORPORATED | ELMED INCORPORATED | 2026-06-09 |
| 00198506091292 | ELMED INCORPORATED | ELMED INCORPORATED | 2026-06-09 |
| 00841785102714 | Symmetry Olsen | ASPEN SURGICAL PRODUCTS, INC. | 2016-09-09 |
| 00841785102042 | Symmetry Olsen | ASPEN SURGICAL PRODUCTS, INC. | 2016-09-09 |
| 00841785101946 | Symmetry Olsen | ASPEN SURGICAL PRODUCTS, INC. | 2016-09-09 |
| 00841785101854 | Symmetry Olsen | ASPEN SURGICAL PRODUCTS, INC. | 2016-09-09 |
| 00841785101724 | Symmetry Olsen | ASPEN SURGICAL PRODUCTS, INC. | 2016-09-09 |
| 00841785103674 | Symmetry Olsen | ASPEN SURGICAL PRODUCTS, INC. | 2016-09-08 |
| 00841785103667 | Symmetry Olsen | ASPEN SURGICAL PRODUCTS, INC. | 2016-09-08 |
| 00841785101755 | Symmetry Olsen | ASPEN SURGICAL PRODUCTS, INC. | 2016-09-07 |
| 00841785103049 | Symmetry Olsen | ASPEN SURGICAL PRODUCTS, INC. | 2016-09-07 |
| 00841785102974 | Symmetry Olsen | ASPEN SURGICAL PRODUCTS, INC. | 2016-09-07 |
| 00841785101700 | Symmetry Olsen | ASPEN SURGICAL PRODUCTS, INC. | 2016-09-07 |
| 00841785101717 | Symmetry Olsen | ASPEN SURGICAL PRODUCTS, INC. | 2016-09-07 |
| 00841785101984 | Symmetry Olsen | ASPEN SURGICAL PRODUCTS, INC. | 2016-09-07 |
| 00841785101816 | Symmetry Olsen | ASPEN SURGICAL PRODUCTS, INC. | 2016-09-07 |
| 00841785102769 | Symmetry Olsen | ASPEN SURGICAL PRODUCTS, INC. | 2016-09-06 |
| 00841785102776 | Symmetry Olsen | ASPEN SURGICAL PRODUCTS, INC. | 2016-09-06 |
| 00841785102899 | Symmetry Olsen | ASPEN SURGICAL PRODUCTS, INC. | 2016-09-06 |
| 00841785102905 | Symmetry Olsen | ASPEN SURGICAL PRODUCTS, INC. | 2016-09-06 |
| 00841785102950 | Symmetry Olsen | ASPEN SURGICAL PRODUCTS, INC. | 2016-09-06 |
| 00841785102967 | Symmetry Olsen | ASPEN SURGICAL PRODUCTS, INC. | 2016-09-06 |
| 00841785103025 | Symmetry Olsen | ASPEN SURGICAL PRODUCTS, INC. | 2016-09-06 |
| 00841785103032 | Symmetry Olsen | ASPEN SURGICAL PRODUCTS, INC. | 2016-09-06 |
| 00841785103162 | Symmetry Olsen | ASPEN SURGICAL PRODUCTS, INC. | 2016-09-06 |
| 00841785103285 | Symmetry Olsen | ASPEN SURGICAL PRODUCTS, INC. | 2016-09-06 |