FDA 510(k) Application Details - K243936

Device Classification Name	More FDA Info for this Device
510(K) Number	K243936
Device Name	StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL)
Applicant	StaClear, INC. 7250 ACC Blvd. Raleigh, NC 27617 US Other 510(k) Applications for this Company
Contact	Jackson Thornton Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QLY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/20/2024
Decision Date	04/03/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review