FDA 510(k) Application Details - K244031

Device Classification Name	More FDA Info for this Device
510(K) Number	K244031
Device Name	Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposable Blood Lancet (Softsure Pro); Disposable Blood Lancet (Softsense)
Applicant	SteriLance Medical (Suzhou) Inc. No.168 PuTuoShan Road, New District Suzhou 215253 CN Other 510(k) Applications for this Company
Contact	Susan Sun Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QRK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/30/2024
Decision Date	02/26/2025
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