SanAgile Ultrasonic Surgery Advanced Portable Controller (SA10) +4 more— 510(k) K242894

Name: FDA 510(k) clearance K242894
Creator: U.S. Food and Drug Administration
Published: 2025-06-18

Substantially Equivalent

Shanghai Saints Sages Surgical Co., Ltd.

FDA 510(k) clearance K242894 for SanAgile Ultrasonic Surgery Advanced Portable Controller (SA10) +4 more, Substantially Equivalent on 2025-06-18. Applicant: Shanghai Saints Sages Surgical Co., Ltd.. Device class: Unclassified.

Clearance details

Device name as filed: 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: Code LFL
Device class: Unclassified
Advisory panel: Unknown
Date received: 2024-09-23
Decision date: 2025-06-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code LFL

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K261448 — neXus Ultrasonic Surgical Aspirator System2026-07-30
K251162 — CUSA® Clarity Ultrasonic Surgical Aspirator System2025-10-08
K243930 — Sonopet iQ Ultrasonic Aspirator System (5500-050-000)2025-03-24
K241700 — Tenex 2nd Generation System2024-11-18
K240493 — CUSA® Clarity Ultrasonic Surgical Aspirator System2024-07-11

Adverse events under product code LFL

product code LFL

Death: 29
Injury: 1,046
Malfunction: 21,642
Total: 22,717

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.