510(k) K000095
K000095 is an FDA 510(k) premarket notification submitted by The Olympus Optical Co. for the device "OLYMPUS SONOSURG TROCAR XT3900 SYSTEM". The FDA issued a decision of Substantially Equivalent on September 26, 2000. The device falls under product code LFL (Instrument, Ultrasonic Surgical), a Class U device. The Olympus Optical Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 26, 2000
- Date Received
- January 13, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Ultrasonic Surgical
- Device Class
- Class U
- Regulation Number
- Review Panel
- SU
- Submission Type