The following data is part of a premarket notification filed by Olympus Medical Systems Corporation with the FDA for Ultrasonic Bipolar Generator Usg-410 With Accessories.
| Device ID | K211838 |
| 510k Number | K211838 |
| Device Name: | Ultrasonic Bipolar Generator USG-410 With Accessories |
| Classification | Instrument, Ultrasonic Surgical |
| Applicant | Olympus Medical Systems Corporation 2951 Ishikawa-cho Hachioji-shi, JP 192-8507 |
| Contact | Toshiyuki Nakajima |
| Correspondent | Anne-marie Keefe Olympus Surgical Technologies Of America 800 West Park Drive Westborough, MA 01581 |
| Product Code | LFL |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-14 |
| Decision Date | 2021-08-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170410758 | K211838 | 000 |
| 14953170370547 | K211838 | 000 |
| 14953170343343 | K211838 | 000 |
| 14953170343312 | K211838 | 000 |
| 14953170308977 | K211838 | 000 |
| 14953170308953 | K211838 | 000 |
| 14953170308939 | K211838 | 000 |
| 14953170308915 | K211838 | 000 |
| 14953170308892 | K211838 | 000 |
| 14953170308878 | K211838 | 000 |
| 14953170306805 | K211838 | 000 |
| 14953170370578 | K211838 | 000 |
| 14953170370608 | K211838 | 000 |
| 04953170407499 | K211838 | 000 |
| 04953170406881 | K211838 | 000 |
| 14953170435826 | K211838 | 000 |
| 14953170409681 | K211838 | 000 |
| 14953170409674 | K211838 | 000 |
| 14953170394581 | K211838 | 000 |
| 14953170394574 | K211838 | 000 |
| 14953170383578 | K211838 | 000 |
| 14953170383547 | K211838 | 000 |
| 14953170383516 | K211838 | 000 |
| 14953170306775 | K211838 | 000 |