The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Thunderbeat Open Fine Jaw Type X Hand Instrument.
| Device ID | K192103 |
| 510k Number | K192103 |
| Device Name: | Thunderbeat Open Fine Jaw Type X Hand Instrument |
| 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 | 2019-08-05 |
| Decision Date | 2020-05-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14953170394581 | K192103 | 000 |
| 14953170394574 | K192103 | 000 |