510(k) K063531
K063531 is an FDA 510(k) premarket notification submitted by Sra Developments, Ltd. for the device "SERIES 3 LOTUS LAPAROSCOPIC ULTRASOUND SURGERY SYSTEM". The FDA issued a decision of Substantially Equivalent on February 22, 2007. The device falls under product code LFL (Instrument, Ultrasonic Surgical), a Class U device. Sra Developments, Ltd. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 22, 2007
- Date Received
- November 22, 2006
- 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