Cleared Traditional

K242894 - SanAgile™ Ultrasonic Surgery Advanced Portable Controller (SA10) (FDA 510(k) Clearance)

Also includes:
SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD14) SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD23) SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD36) SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD45)
K242894 · Shanghai Saints Sages Surgical Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2025
Decision
268d
Days
-
Risk

K242894 is an FDA 510(k) clearance for the SanAgile™ Ultrasonic Surgery Advanced Portable Controller (SA10). Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Shanghai Saints Sages Surgical Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on June 18, 2025 after a review of 268 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Shanghai Saints Sages Surgical Co., Ltd. devices

Submission Details

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
154d slower than avg
Panel avg: 114d · This submission: 268d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LFL Instrument, Ultrasonic Surgical
Device Class -

Regulatory Consultant

Emergo Global Consulting, LLC
Giselle Zhang

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LFL Instrument, Ultrasonic Surgical

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