510(k) submissions
All indexed GEI clearances · showing 51–74 of 74
| K number | Device name | Company | Technology | Class | Decision |
|---|---|---|---|---|---|
| K242996 | EndyMed PRO MAXPain Management | Endymed Medical, Ltd.Israel | RF Ablation | Class 2 | 2025-06-10 |
| K242907 | DELPHI SystemSurgery | CnS Medical Co., Ltd.Korea, Republic of | RF Ablation | Class 2 | 2025-06-06 |
| K250657 | gi2000 Electrosurgical GeneratorSurgery | Cintron Medical CorporationUnited States | RF Generator | Class 2 | 2025-06-03 |
| K251238 | Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000); Vasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield (VH-6001); Vasoview Hemopro 3 Power Supply (VH-6010)Surgery | Maquet Cardiovascular, LLCUnited States | Endoscopic Instrument | Class 2 | 2025-05-30 |
| K250048 | NEUROMARK System (NMK00301)Surgery | Neurent Medical , Ltd.Ireland | RF Ablation | Class 2 | 2025-05-29 |
| K243176 | BLESSING System | Cellah Medical Co., Ltd.Korea, Republic of | — | Class 2 | 2025-05-16 |
| K240857 | Youmagic FLM System (YM5-U1)Surgery | We Medical Technology (Wuxi) Co., Ltd.China | RF Ablation | Class 2 | 2025-05-15 |
| K250400 | Vigeon Laparoscopic Universal Smoke Evacuator (VG003)Surgery | Vigeon Technology Co., Ltd.Taiwan | Other | Class 2 | 2025-05-09 |
| K242469 | RFMagik LiteSurgery | Agnes Medical Co., Ltd.Korea, Republic of | RF Ablation | Class 2 | 2025-04-25 |
| K250327 | OptaBlate Radiofrequency (RF) Generator SystemPain Management | Stryker InstrumentsUnited States | RF Generator | Class 2 | 2025-04-15 |
| K242773 | Electro Lube NXTSurgery | SterisUnited States | Other | Class 2 | 2025-04-15 |
| K243451 | FiAPC plus probesSurgery | Erbe Elektromedizin GmbHUnited States | RF Ablation | Class 2 | 2025-03-21 |
| K242241 | SunnyPain Management | ShenB Co., Ltd.Korea, Republic of | RF Ablation | Class 2 | 2025-03-19 |
| 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 |
| K250200 | InbellaBody SystemPain Management | Inbella Medical, Inc.Canada | RF Ablation | Class 2 | 2025-02-11 |
| 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 |
| K243139 | Reverso Pro SystemSurgery | Indiba S. A. U.Spain | RF Ablation | Class 2 | 2025-01-22 |
| K240311 | JETT Medical II | Compex, Spol, S.R.O.Czechia | — | Class 2 | 2025-01-22 |
| K243929 | Oligio XSurgery | Wontech Co., Ltd.Korea, Republic of | RF Ablation | Class 2 | 2025-01-21 |
| K243067 | The ETHICON™ Total Energy SystemSurgery | Ethicon Endo-Surgery, LLC (A Johnson and Johnson Company)United States | RF Generator | Class 2 | 2025-01-17 |
| K243737 | Inbella RF SystemSurgery | Inbella Medical, Inc.Canada | RF Ablation | Class 2 | 2025-01-03 |
| K233118 | DUET-V (Model: ESK-3261DV)Surgery | Eunsung Global CorpKorea, Republic of | RF Ablation | Class 2 | 2025-01-03 |