About This 510(k) Submission
K242894 is an FDA 510(k) clearance for the 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), 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 review panel.