The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for 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.
| Device ID | K172610 |
| 510k 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 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Olympus Medical Systems Corp. 2951 Ishikawa-cho Hachioji-shi, JP 192-8507 |
| Contact | Toshiyuki Nakajima |
| Correspondent | Christina Flores Gyrus ACMI Inc. 136 Turnpike Road Southborough, MA 01772 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-31 |
| Decision Date | 2018-04-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14953170409681 | K172610 | 000 |
| 14953170409674 | K172610 | 000 |
| 14953170383585 | K172610 | 000 |
| 14953170383578 | K172610 | 000 |
| 14953170383554 | K172610 | 000 |
| 14953170383547 | K172610 | 000 |
| 14953170383523 | K172610 | 000 |
| 14953170383516 | K172610 | 000 |