Acera Surgical Inc

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
7
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1030-2022Class IIRestrata, Part Number RWM1-2X2March 21, 2022

Recent 510(k) Clearances

K-NumberDeviceDate
K251224Restrata Soft Tissue Reinforcement (STR)June 20, 2025
K223725Restrata® MiniMatrixMay 18, 2023
K193583Restrata®September 25, 2020
K172603Cerafix Dura SubstituteNovember 27, 2017
K170300Restrata Wound MatrixApril 26, 2017
K161278Cerafix Dura SubstituteAugust 8, 2016
K153613Cerafix Dura SubstituteMarch 16, 2016