FDA 510(k) Application Details - K250591

Device Classification Name	More FDA Info for this Device
510(K) Number	K250591
Device Name	Anovo Surgical System (6Ne)
Applicant	Momentis Surgical Ltd. 6 Yoni Netanyahu Street Or Yehuda 6037604 IL Other 510(k) Applications for this Company
Contact	Maya Leib Shlomo Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QNM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/27/2025
Decision Date	06/06/2025
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