Product code GEI
- Product
- Electrosurgical, Cutting & Coagulation & Accessories
- 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).
- Description
- General & Plastic Surgery Microwave Medical Products
- Regulation number
- 878.4400
- Radiation type
- Microwave EMF
- Applicable standards
- No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]
Current FDA Classification
- 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).
Related Records
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K252740 | Voyant® Open Fusion Device (EB240/Open Fusion) | Applied Medical Resources Corp. | 2025-11-04 |
| K252412 | Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator) | Applied Medical Resources Corporation | 2025-10-31 |
| K250275 | PrecisePath Radiofrequency Puncture Generator and PrecisePath Footswitch | Baylis Medical Technologies, Inc. | 2025-10-28 |
| K250126 | ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M) | Livsmed, Inc. | 2025-10-21 |
| K250852 | Coolfase | Asterasys Co., Ltd. | 2025-10-16 |
| K252367 | InbellaMulti System | Inbella Medical, Inc. | 2025-10-15 |
| K252150 | Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 45cm (TB2-0545FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 35cm (TB2-0535FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 25cm (TB2-0525FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 20cm (TB2-0520FC) | Olympus Medical Systems Corporation | 2025-10-07 |
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00845854035590 | CONCEPT | Conmed Corporation | 2026-03-24 |
| 00190776417932 | Millennium | Avalign Technologies, Inc. | 2026-03-23 |
| 00190776417956 | Millennium | Avalign Technologies, Inc. | 2026-03-23 |
| 00190776418076 | Millennium | Avalign Technologies, Inc. | 2026-03-23 |
| 00190776418281 | Millennium | Avalign Technologies, Inc. | 2026-03-23 |
| 00653405013924 | CONMED | Conmed Corporation | 2026-03-23 |
| 00198506089732 | ELMED INCORPORATED | ELMED INCORPORATED | 2026-03-20 |
| 00198506089749 | ELMED INCORPORATED | ELMED INCORPORATED | 2026-03-20 |
| 08800020108272 | DENSITY Tip | Jeisys Medical Inc. | 2026-03-16 |
| 08800020108203 | DENSITY | Jeisys Medical Inc. | 2026-03-16 |
| 08800020108296 | DENSITY Tip | Jeisys Medical Inc. | 2026-03-16 |
| 08800020108302 | DENSITY Tip | Jeisys Medical Inc. | 2026-03-16 |
| 08800020108319 | DENSITY Tip | Jeisys Medical Inc. | 2026-03-16 |
| 08800020108326 | DENSITY Tip | Jeisys Medical Inc. | 2026-03-16 |
| 08800020108395 | POTENZA | Jeisys Medical Inc. | 2026-03-16 |
| 08800020108401 | POTENZA | Jeisys Medical Inc. | 2026-03-16 |
| 08800020108425 | POTENZA | Jeisys Medical Inc. | 2026-03-16 |
| 08800020108289 | DENSITY Tip | Jeisys Medical Inc. | 2026-03-16 |
| 08800020108197 | DENSITY | Jeisys Medical Inc. | 2026-03-16 |
| 08800020108180 | DENSITY | Jeisys Medical Inc. | 2026-03-16 |
| 08800020108173 | DENSITY | Jeisys Medical Inc. | 2026-03-16 |
| 08800020108166 | DENSITY | Jeisys Medical Inc. | 2026-03-16 |
| 08800020101525 | POTENZA | Jeisys Medical Inc. | 2026-03-16 |
| 00198506089565 | ELMED INCORPORATED | ELMED INCORPORATED | 2026-03-13 |
| 10884450587796 | STAR™ | Merit Medical Systems, Inc. | 2026-03-11 |
| 10884450587802 | STAR™ | Merit Medical Systems, Inc. | 2026-03-11 |
| 08800020107299 | POTENZA Tip | Jeisys Medical Inc. | 2026-03-10 |
| 20845854035594 | CONCEPT | Conmed Corporation | 2016-09-24 |
| 30653405033251 | ULTRACLEAN | Conmed Corporation | 2016-09-24 |
| 30653405013925 | CONMED | Conmed Corporation | 2016-09-24 |