THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS) +2 more— 510(k) K254056
Substantially EquivalentOlympus Medical Systems Corp.
FDA 510(k) clearance K254056 for THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS) +2 more, Substantially Equivalent on 2026-07-01. Applicant: Olympus Medical Systems Corp.. Device class: 2.
Clearance details
- Device name as filed
- 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)
- Applicant
- Olympus Medical Systems Corp.
- Product code
- Code GEI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hachioji-Shi, JP
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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, through . 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.