Olympus Medical Systems Corporation · Class II · Cleared Oct 7, 2025
| K-number | K252150 |
| Device name | 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) |
| Applicant | Olympus Medical Systems Corporation |
| Product code | GEI |
| Device class | Class II |
| Decision date | Oct 7, 2025 |
| Decision | Substantially Equivalent |
| Regulation | — |
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