510(k) K172691
K172691 is an FDA 510(k) premarket notification submitted by Olympus Medical Systems Corp. for the device "Ultrasonic Generator". The FDA issued a decision of Substantially Equivalent on Oct 4, 2017. The device falls under product code LFL (Instrument, Ultrasonic Surgical), a Class U device. Olympus Medical Systems Corp. has 103 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 4, 2017
- Date Received
- Sep 6, 2017
- Clearance Type
- Special
- 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)