K242894 is an FDA 510(k) clearance for the SanAgile™ Ultrasonic Surgery Advanced Portable Controller (SA10). This device is classified as a Instrument, Ultrasonic Surgical.
Submitted by Shanghai Saints Sages Surgical Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on June 18, 2025, 268 days after receiving the submission on September 23, 2024.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K242894 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 23, 2024 |
| Decision Date | June 18, 2025 |
| Days to Decision | 268 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | LFL - Instrument, Ultrasonic Surgical |
| Device Class | - |