510(k) K111202 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
SURGICAL TISSUE MANAGEMENT SYSTEM
| Applicant | Olympus Medical Systems Corp., Center Valley PA, US |
| Decision | Substantially Equivalent, Jan 20, 2012 |
| Received | Apr 29, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111202
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 17, 2026 | Olympus Corporation of the Americas Olympus Thunderbeat, 5 mm, 45 cm Front-Actuated Grip Open, Classified |
LFL | None listed |
| Feb 17, 2026 | Olympus Corporation of the Americas Olympus Thunderbeat 5 mm, 35 cm, Front-Actuated Grip Open, Classified |
LFL | None listed |
| Feb 17, 2026 | Olympus Corporation of the Americas Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip Open, Classified |
LFL | None listed |
| Feb 17, 2026 | Olympus Corporation of the Americas Olympus Thunderbeat, 5 mm, 45 cm, Pistol Grip Open, Classified |
LFL | None listed |
| Feb 17, 2026 | Olympus Corporation of the Americas Olympus Thunderbeat, 5mm, 35 cm, Pistol Grip Open, Classified |
LFL | None listed |
| Feb 17, 2026 | Olympus Corporation of the Americas Olympus Thunderbeat, 5 mm, 45 cm Inline Grip Open, Classified |
LFL | None listed |
| Feb 17, 2026 | Olympus Corporation of the Americas Olympus Thunderbeat, 5 mm, 35 cm, Inline Grip Open, Classified |
LFL | None listed |
| Feb 17, 2026 | Olympus Corporation of the Americas Olympus Thunderbeat, 5 mm, 20 cm, Inline Grip Open, Classified |
LFL | None listed |
| Feb 17, 2026 | Olympus Corporation of the Americas Olympus Thunderbeat 5 mm, 10 cm, Inline Grip Open, Classified |
LFL | None listed |
| Dec 5, 2013 | Olympus America Inc. TB-0545PC: THUNDERBEAT 5 mm , 45 em, Pistol Grip TB-0535PC: THUNDERBEAT 5 mm, 35 em, Pi stol Grip TB-0545IC: THUNDERBEAT 5 mm, 45 em, In line Grip TB-0535IC: THUNDERBEAT 5 mm, 35 em, Inline Grip TB-05 Terminated |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.