510(k) submissions
Filtered by Energy Device · showing 1–2 of 2
| K number | Device name | Company | Technology | Class | Decision |
|---|---|---|---|---|---|
| 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 |
| K252215 | InbellaMAX SystemOther | Inbella Medical, Inc.Canada | Energy Device | Class 2 | 2025-07-25 |