510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K242894Substantially Equivalent

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)

Shanghai Saints Sages Surgical Co., Ltd., Shanghai, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K242894 is the FDA 510(k) clearance record for 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), cleared for Shanghai Saints Sages Surgical Co., Ltd. on under FDA product code LFL (Instrument, Ultrasonic Surgical). FDA records list one 510(k) clearance for Shanghai Saints Sages Surgical Co., Ltd. As of , FDA records show no recalls naming K242894.

Clearance record

Decision date
Received
(268 days to decision)
Product code
LFL Instrument, Ultrasonic Surgical
Device class
Unclassified
Review panel
Unknown
Applicant
Shanghai Saints Sages Surgical Co., Ltd. #19, Ln. 388, Shengrong Rd., Pilot Free Trade Zone, Shanghai, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LFL

Trailing 12 months
1 clearance under product code LFL in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LFL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260