Cleared Traditional

K242894 - SanAgile Ultrasonic Surgery Advanced Po...

Also marketed or referenced as:
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

FDA 510(k) Submission Details - K242894

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
153d slower than avg
Panel avg: 115d · This submission: 268d
Pathway characteristics
Predicate-based equivalence.

LFL Device Classification - Class 0,

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

All 94
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