K211838 is an FDA 510(k) clearance for the Ultrasonic Bipolar Generator USG-410 with accessories. This device is classified as a Instrument, Ultrasonic Surgical.
Submitted by Olympus Medical Systems Corporation (Hachioji-Shi, JP). The FDA issued a Cleared decision on August 4, 2021, 51 days after receiving the submission on June 14, 2021.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K211838 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 14, 2021 |
| Decision Date | August 04, 2021 |
| Days to Decision | 51 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | LFL — Instrument, Ultrasonic Surgical |
| Device Class | — |