510(k) K151101
K151101 is an FDA 510(k) premarket notification submitted by Sra Developments, Ltd. for the device "Lotus Series 4 Ultrasonic Surgical System & Accessories". The FDA issued a decision of Substantially Equivalent on July 17, 2015. 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
- July 17, 2015
- Date Received
- April 24, 2015
- Clearance Type
- Special
- 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