FDA 510(k) Application Details - K243576

Device Classification Name	Negative Pressure Wound Therapy Powered Suction Pump   More FDA Info for this Device
510(K) Number	K243576
Device Name	Negative Pressure Wound Therapy Powered Suction Pump
Applicant	Smith & Nephew Medical Ltd 101 Hessle Road Hull HU3 2BN GB Other 510(k) Applications for this Company
Contact	Ruby Uttley Other 510(k) Applications for this Contact
Regulation Number	878.4780   More FDA Info for this Regulation Number
Classification Product Code	OMP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/19/2024
Decision Date	02/18/2025
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