K063531 is an FDA 510(k) clearance for the SERIES 3 LOTUS LAPAROSCOPIC ULTRASOUND SURGERY SYSTEM. This device is classified as a Instrument, Ultrasonic Surgical.
Submitted by Sra Developments, Ltd. (Ashburton, Devon, GB). The FDA issued a Cleared decision on February 22, 2007, 92 days after receiving the submission on November 22, 2006.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K063531 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 22, 2006 |
| Decision Date | February 22, 2007 |
| Days to Decision | 92 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | LFL - Instrument, Ultrasonic Surgical |
| Device Class | - |