FDA 510(k) Application Details - K250984

Device Classification Name	More FDA Info for this Device
510(K) Number	K250984
Device Name	Maestro System (REF100)
Applicant	Moon Surgical 9 rue d'Enghien Paris 75010 FR Other 510(k) Applications for this Company
Contact	Anne Osdoit Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QZB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/31/2025
Decision Date	06/27/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review