Shanghai Saints Sages Surgical Co., Ltd. · Class U · Cleared Jun 18, 2025
| K-number | K242894 |
| Device name | SanAgile Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile Ultrasonic Surgery Advanced Dissector (SASD14); SanAgile Ultrasonic Surgery Advanced Dissector (SASD23); SanAgile Ultrasonic Surgery Advanced Dissector (SASD36); SanAgile Ultrasonic Surgery Advanced Dissector (SASD45) |
| Applicant | Shanghai Saints Sages Surgical Co., Ltd. |
| Product code | LFL |
| Device class | Class U |
| Decision date | Jun 18, 2025 |
| Decision | Substantially Equivalent |
| Regulation | — |
The SanAgile™ Ultrasonic Surgery Advanced system is a portable ultrasonic surgical instrument for vessel sealing and soft tissue incisions with minimal thermal injury. It consists of a compact SA10 controller that powers single-use dissectors (SASD14, SASD23, SASD36, SASD45) in laparoscopic and open surgical procedures. The dissectors can coagulate isolated vessels up to 5 mm in diameter using a minimum power button.
The subject device uses pure ultrasonic energy at 55.5 kHz with a fixed 35W maximum output, compared to the predicate's hybrid ultrasonic and Adaptive Tissue Technology platform. The subject has two fixed energy buttons (MIN/MAX) without user adjustment, versus the predicate's three adjustable energy buttons. The subject offers a 14 cm shaft length option; the predicate only offers 23, 36, and 45 cm. Both share identical drive frequency, clamping force, jaw design, and maximum vessel size specifications.
ISO 10993 biocompatibility testing (cytotoxicity, sensitization, acute toxicity, intracutaneous reactivity); USP <151> pyrogen testing; IEC 60601-1 electrical safety; IEC 60601-1-2 electromagnetic disturbance; IEC 60601-4-2 electromagnetic immunity; IEC 62304 software validation; ASTM D4169 transportation testing; and SAL 10⁻⁶ sterilization validation per internal standards.
The subject device shares the same intended use (ultrasonic vessel sealing and soft tissue incision in open and laparoscopic surgery) and core technological platform (ultrasonic energy at identical frequency and power output) as the predicate. Differences in control interface (fixed vs. adjustable buttons) and available shaft lengths are design variations that do not raise new safety or effectiveness questions. Non-clinical testing demonstrates the device meets performance specifications and animal studies confirm intended function, establishing that the subject performs as safely and effectively as the legally marketed predicate.
View the full FDA submission: accessdata.fda.gov