K242894
- 510(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. CN
- Product code
- LFL — Instrument, Ultrasonic Surgical
- Decision date
- 2025-06-18
- Date received
- 2024-09-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 3.0 MB · U.S. public domain
Also available from FDA: K242894.pdf
Official FDA record: K242894
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.