510(k) K254056— THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S (TB-0520FCS)

Substantially Equivalent

Olympus Medical Systems Corp.

Clearance details

Applicant: Olympus Medical Systems Corp.
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 2025-12-17
Decision date: 2026-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hachioji-Shi, JP

Adverse events under product code GEI

product code GEI

Death: 133
Injury: 7,585
Malfunction: 35,808
Other: 44
Total: 43,570

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.