FDA 510(k) Application Details - K243638

Device Classification Name	Apparatus, Suction, Ward Use, Portable, Ac-Powered   More FDA Info for this Device
510(K) Number	K243638
Device Name	Apparatus, Suction, Ward Use, Portable, Ac-Powered
Applicant	MicroVention 35 Enterprise Aliso Viejo, CA 92656 US Other 510(k) Applications for this Company
Contact	Alick Tan Other 510(k) Applications for this Contact
Regulation Number	878.4780   More FDA Info for this Regulation Number
Classification Product Code	JCX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/25/2024
Decision Date	06/13/2025
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