Thunderbeat
by Olympus Medical Systems Corp.
510(k) K132703
Thunderbeat is a Class II device made by Olympus Medical Systems Corp., cleared under FDA 510(k) K132703 on 19 May 2014, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK132703 | Date19 May 2014 | StatusActive |
Official records
- FDA 510(k) database K132703
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GEI
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4400
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K132703
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| THUNDERBEAT Open Extended Jaw TB-0920OE | TB-0920OE | 04953170343308 | — | No longer on the market |
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