510(k) submissions
Filtered by Surgery · showing 1–50 of 61
| K number | Device name | Company | Technology | Class | Decision |
|---|---|---|---|---|---|
| K261202 | ENTire IRE SystemSurgery | Entire Medical , Ltd.Israel | RF Ablation | Class 2 | 2026-05-29 |
| K252833 | VIVA combo RF SystemSurgery | Starmed Co., Ltd.Korea, Republic of | RF Ablation | Class 2 | 2026-05-26 |
| K253134 | LAGIS Endoscopic Instruments- Scissors (EI-330S EI-330S-T EI-330MS EI-330MS-T)Surgery | Lagis Enterprise Co., Ltd.Taiwan | Endoscopic Instrument | Class 2 | 2026-05-20 |
| K260522 | RhinAer+ StylusSurgery | Aerin Medical, Inc.United States | RF Ablation | Class 2 | 2026-05-18 |
| K253917 | ARION ARC SystemSurgery | Plasma Surgical, Inc.United States | RF Ablation | Class 2 | 2026-04-10 |
| K253777 | Ascblue (8010)Surgery | Ascblue CorporationUnited States | RF Generator | Class 2 | 2026-04-10 |
| K260466 | Multifunctional Operational Dissectors (Electrosurgical Pencils);Multifunctional Operational Dissectors (Disposable Electrode)Surgery | Zhejiang shuyou Surgical Instrument Co., Ltd.China | RF Ablation | Class 2 | 2026-04-07 |
| K260397 | SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002)Surgery | Hironic Co., Ltd.Korea, Republic of | RF Ablation | Class 2 | 2026-04-06 |
| K253405 | Prana SystemSurgery | Prana SurgicalUnited States | RF Ablation | Class 2 | 2026-04-01 |
| K254122 | FLOW FLEXTEND Wand (72290039)Surgery | ArthroCare CorporationUnited States | RF Ablation | Class 2 | 2026-03-30 |
| K260255 | AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001)Surgery | Aventix Medical, Inc.United States | RF Ablation | Class 2 | 2026-03-27 |
| K253680 | LYNX COBLATION Laryngeal Wand (72290254)Surgery | ArthroCare CorporationUnited States | RF Ablation | Class 2 | 2026-03-25 |
| K252487 | POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA)Surgery | Gyrus Acmi, Inc.United States | RF Ablation | Class 2 | 2026-03-02 |
| K260287 | SP Electrocautery Device (SP20)Surgery | Single Pass, Inc.United States | RF Ablation | Class 2 | 2026-02-24 |
| 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 |
| K251435 | InbellaIgnite RF SystemSurgery | Inbella Medical, Inc.Canada | RF Ablation | Class 2 | 2026-01-27 |
| K251254 | Ignite RF SystemSurgery | InMode , Ltd.Israel | RF Ablation | Class 2 | 2026-01-15 |
| K251996 | ENTire IRE SystemSurgery | Entire Medical , Ltd.Israel | RF Ablation | Class 2 | 2026-01-14 |
| 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 |
| K250126 | ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M)Surgery | Livsmed, Inc.Korea, Republic of | RF Ablation | Class 2 | 2025-10-21 |
| K250852 | CoolfaseSurgery | Asterasys Co., Ltd.Korea, Republic of | RF Ablation | Class 2 | 2025-10-16 |
| 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)Surgery | Olympus Medical Systems CorporationJapan | Energy Device | Class 2 | 2025-10-07 |
| K250688 | Cedar™ Endovenous Radiofrequency Catheter (ERA-C70-US); Cedar™ Endovenous Radiofrequency Catheter (ERA-C30-US); Endovenous Radiofrequency Generator (ERA-G5-US)Surgery | Acotec Scientific Co., Ltd.China | RF Ablation | Class 2 | 2025-10-07 |
| K251899 | E BlatorSurgery | New Deantronics Taiwan , Ltd.Taiwan | RF Ablation | Class 2 | 2025-10-01 |
| K251334 | NEW DOUBLO 2.0Surgery | Hironic Co., Ltd.Korea, Republic of | RF Ablation | Class 2 | 2025-09-29 |
| K252043 | Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus (WB990311); Bipolar applicator CelonProBreath (WB990210); Bipolar applicator CelonProSleep plus (WB990211)Surgery | Olympus Winter & Ibe GmbHUnited States | RF Ablation | Class 2 | 2025-09-23 |
| K250483 | PhotonBlade 3; PhotonBlade 3 Smoke EvacuationSurgery | Stryker InstrumentsUnited States | RF Ablation | Class 2 | 2025-09-09 |
| K250217 | AGNES UltraSurgery | Agnes Medical Co., Ltd.Korea, Republic of | RF Ablation | Class 2 | 2025-09-03 |
| 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 |
| K243713 | Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A, AN-F3A, AN-IL, AN-SL, AN-W3B, AN-F1A, AN-F3B, AN-B3A)Surgery | Agnes Medical Co., Ltd.Korea, Republic of | RF Ablation | 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 |
| K251327 | XERFSurgery | Lutronic CorporationKorea, Republic of | RF Ablation | Class 2 | 2025-08-11 |
| K250065 | DENSITY; DENZA; DENSITY NoirSurgery | Jeisys Medical IncorporatedKorea, Republic of | RF Ablation | Class 2 | 2025-07-08 |
| K243120 | HybridAPC probeSurgery | Erbe Elektromedizin GmbHUnited States | RF Ablation | Class 2 | 2025-06-20 |
| K251235 | Electrosurgical PadsSurgery | Baisheng Medical Co., Ltd.China | RF Ablation | Class 2 | 2025-06-19 |
| 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 |
| 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 |