FDA 510(k) Application Details - K251224

Device Classification Name	More FDA Info for this Device
510(K) Number	K251224
Device Name	Restrata Soft Tissue Reinforcement (STR)
Applicant	Acera Surgical, Inc. 1650 Des Peres Rd. Suite 120 St. Louis, MO 63131 US Other 510(k) Applications for this Company
Contact	Tamas Kovacs Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OXF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/21/2025
Decision Date	06/20/2025
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