FDA 510(k) Application Details - K242157

Device Classification Name	More FDA Info for this Device
510(K) Number	K242157
Device Name	Anovo Surgical System (Model 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	07/23/2024
Decision Date	10/21/2024
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