FDA 510(k) Application Details - K242894

Device Classification Name	Instrument, Ultrasonic Surgical   More FDA Info for this Device
510(K) Number	K242894
Device Name	Instrument, Ultrasonic Surgical
Applicant	Shanghai Saints Sages Surgical Co., Ltd. No.19, Lane 388, Shengrong Road, Pilot Free Trade Zone, Shanghai 201210 CN Other 510(k) Applications for this Company
Contact	Xue Ting Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LFL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/23/2024
Decision Date	06/18/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review