FDA 510(k) Application Details - K242541

Device Classification Name	Clip, Implantable   More FDA Info for this Device
510(K) Number	K242541
Device Name	Clip, Implantable
Applicant	Synovis Micro Companies Alliance A subsidiary of Baxter Int 439 Industrial Lane Birmingham, AL 35211 US Other 510(k) Applications for this Company
Contact	Julie Carlston Other 510(k) Applications for this Contact
Regulation Number	878.4300   More FDA Info for this Regulation Number
Classification Product Code	FZP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/26/2024
Decision Date	01/15/2025
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