THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S
FDA 510(k) clearance K172610 · decided 2018-04-17
Clearance details
- K-number
- K172610
- Device name
- THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S
- Applicant
- Olympus Medical Systems Corp.
- Decision
- Substantially Equivalent
- Date received
- 2017-08-31
- Decision date
- 2018-04-17
- Days to decision
- 229 days
- Clearance type
- Traditional
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Hachioji-Shi, JP
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Olympus Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type S recall (Z-1371-2026) | Olympus Corporation of the Americas | 2026-02-17 |
| Olympus Thunderbeat, 5 mm, 35 cm, Front-Actuated Grip Type S recall (Z-1372-2026) | Olympus Corporation of the Americas | 2026-02-17 |
| Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip Type S recall (Z-1373-2026) | Olympus Corporation of the Americas | 2026-02-17 |