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 X, Thunderbeat 5 Mm, 35 Cm, Front-actuated Grip Type X, Thunderbeat 5 Mm, 45 Cm, Front-actuated Grip Type X.
| Device ID | K180575 |
| 510k Number | K180575 |
| Device Name: | THUNDERBEAT 5 Mm, 20 Cm, Front-actuated Grip Type X, THUNDERBEAT 5 Mm, 35 Cm, Front-actuated Grip Type X, THUNDERBEAT 5 Mm, 45 Cm, Front-actuated Grip Type X |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Olympus Medical Systems Corp. 2951 Ishikawa-cho Hachioji-shi, JP 192-8507 |
| Contact | Toshiyuki Nakajima |
| Correspondent | Graham A.l. Baillie 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 | 2018-03-05 |
| Decision Date | 2018-07-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14953170392235 | K180575 | 000 |
| 14953170392228 | K180575 | 000 |
| 14953170392204 | K180575 | 000 |
| 14953170392198 | K180575 | 000 |
| 14953170392174 | K180575 | 000 |
| 14953170392167 | K180575 | 000 |