510(k) submissions
Filtered by RF Generator · showing 1–18 of 18
| K number | Device name | Company | Technology | Class | Decision |
|---|---|---|---|---|---|
| K253777 | Ascblue (8010)Surgery | Ascblue CorporationUnited States | RF Generator | Class 2 | 2026-04-10 |
| K253750 | BTL-785NEHPain Management | BTL Industries, Inc.United States | RF Generator | Class 2 | 2026-03-17 |
| K251813 | CURIS II RF Generator (REF 360100-05)Surgery | Sutter Medizintechnik GmbHGermany | RF Generator | Class 2 | 2026-02-11 |
| K254290 | ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)Surgery | Shenzhen Peninsula Medical GroupChina | RF Generator | Class 2 | 2026-01-30 |
| K254220 | Reusable 3 Button Fingerswitch WandSurgery | Soniquence, LLCUnited States | RF Generator | Class 2 | 2026-01-27 |
| K251566 | TS-RF Generator (STS10)Surgery | Starmed Co., Ltd.Korea, Republic of | RF Generator | Class 2 | 2025-11-17 |
| K250275 | PrecisePath™ Radiofrequency Puncture Generator and PrecisePath™ FootswitchSurgery | Baylis Medical Technologies, Inc.Canada | RF Generator | Class 2 | 2025-10-28 |
| K251108 | Erbe ESU Model VIO® 3n with AccessoriesSurgery | Erbe Elektromedizin GmbHUnited States | RF Generator | Class 2 | 2025-08-29 |
| K252316 | Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100)Surgery | Venclose, Inc.United States | RF Generator | Class 2 | 2025-08-19 |
| K252083 | HOTWIRE™ System RF Generator and Footswitch (optional accessory)Surgery | Atraverse Medical, Inc.United States | RF Generator | Class 2 | 2025-08-12 |
| K252211 | Duoblade Plus SE (DB1EP, DB1EP-T, DB1EP-H, DB1EP-TH); Duoblade Prime (DB1P, DB1P-T, DB1P-H, DB1P-TH)Surgery | Cnc TechnologiesKorea, Republic of | RF Generator | Class 2 | 2025-08-11 |
| K250657 | gi2000 Electrosurgical GeneratorSurgery | Cintron Medical CorporationUnited States | RF Generator | Class 2 | 2025-06-03 |
| K250327 | OptaBlate Radiofrequency (RF) Generator SystemPain Management | Stryker InstrumentsUnited States | RF Generator | Class 2 | 2025-04-15 |
| K243918 | Vasoview Hemopro 3 Power SupplySurgery | Maquet Cardiovascular, LLCUnited States | RF Generator | Class 2 | 2025-02-26 |
| K241832 | Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System (Unicorn+ II); Unicorn+ RF System (Unicorn+ III)Surgery | Boston Aesthetics, Inc.United States | RF Generator | Class 2 | 2025-02-13 |
| K242983 | CROMA Electrosurgical Generator (PRD-EMR-050)Surgery | Creo Medical, Ltd.United Kingdom | RF Generator | Class 2 | 2025-02-05 |
| K250068 | Venclose digiRF Generator (VCRFG1)Surgery | Venclose, Inc.United States | RF Generator | Class 2 | 2025-02-04 |
| K243067 | The ETHICON™ Total Energy SystemSurgery | Ethicon Endo-Surgery, LLC (A Johnson and Johnson Company)United States | RF Generator | Class 2 | 2025-01-17 |