510(k) K211838
K211838 is an FDA 510(k) premarket notification submitted by Olympus Medical Systems Corporation for the device "Ultrasonic Bipolar Generator USG-410 with accessories". The FDA issued a decision of Substantially Equivalent on Aug 4, 2021. The device falls under product code LFL (Instrument, Ultrasonic Surgical), a Class U device. Olympus Medical Systems Corporation has 85 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 4, 2021
- Date Received
- Jun 14, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Ultrasonic Surgical
- Device Class
- Class U
- Review Panel
- SU
- Submission Type
- 510(k)