510(k) K252150 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
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 S
| Applicant | Olympus Medical Systems Corporation, Hachioji-Shi, JP |
| Decision | Substantially Equivalent, Oct 7, 2025 |
| Received | Jul 9, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252150
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 17, 2026 | Olympus Corporation of the Americas Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm. Model Number: TB2-0520FC. Open, Classified |
GEI | None listed |
| Apr 17, 2026 | Olympus Corporation of the Americas Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 25cm. Model Number: TB2-0525FC. Open, Classified |
GEI | None listed |
| Apr 17, 2026 | Olympus Corporation of the Americas Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm. Model Number: TB2-0535FC. Open, Classified |
GEI | None listed |
| Apr 17, 2026 | Olympus Corporation of the Americas Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm. Model Number: TB2-0545FC. Open, Classified |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.