FDA 510(k) Application Details - K242368

Device Classification Name	More FDA Info for this Device
510(K) Number	K242368
Device Name	Symani Surgical System
Applicant	Medical Microinstruments, Inc. Via Egidio Giannessi 54 Pisa 56121 IT Other 510(k) Applications for this Company
Contact	Zainab Amini Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	SAQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/09/2024
Decision Date	02/07/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review