510(k) submissions
Filtered by Tissue Repair · showing 1–20 of 20
| K number | Device name | Company | Technology | Class | Decision |
|---|---|---|---|---|---|
| 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 |
| 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 |
| K253680 | LYNX COBLATION Laryngeal Wand (72290254)Surgery | ArthroCare CorporationUnited States | RF Ablation | Class 2 | 2026-03-25 |
| 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 |
| 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 |
| 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 |
| K250483 | PhotonBlade 3; PhotonBlade 3 Smoke EvacuationSurgery | Stryker InstrumentsUnited States | RF Ablation | Class 2 | 2025-09-09 |
| K251108 | Erbe ESU Model VIO® 3n with AccessoriesSurgery | Erbe Elektromedizin GmbHUnited States | RF Generator | Class 2 | 2025-08-29 |
| K243120 | HybridAPC probeSurgery | Erbe Elektromedizin GmbHUnited States | RF Ablation | Class 2 | 2025-06-20 |
| K242907 | DELPHI SystemSurgery | CnS Medical Co., Ltd.Korea, Republic of | RF Ablation | Class 2 | 2025-06-06 |
| 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 |
| K250327 | OptaBlate Radiofrequency (RF) Generator SystemPain Management | Stryker InstrumentsUnited States | RF Generator | Class 2 | 2025-04-15 |
| K243451 | FiAPC plus probesSurgery | Erbe Elektromedizin GmbHUnited States | RF Ablation | Class 2 | 2025-03-21 |
| K243918 | Vasoview Hemopro 3 Power SupplySurgery | Maquet Cardiovascular, LLCUnited States | RF Generator | Class 2 | 2025-02-26 |
| K242983 | CROMA Electrosurgical Generator (PRD-EMR-050)Surgery | Creo Medical, Ltd.United Kingdom | RF Generator | Class 2 | 2025-02-05 |