Asensus Surgical Inc

FDA Regulatory Profile

Summary

Total Recalls
1 (1 Class I)
510(k) Clearances
5
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0170-2024Class ISenhance Surgical System, which includes: Manipulator Arm, ISU Configuration ( Catalog Number X90077September 15, 2023

Recent 510(k) Clearances

K-NumberDeviceDate
K233866Senhance Surgical SystemJuly 19, 2024
K223095Senhance Surgical SystemMarch 16, 2023
K220889Senhance Surgical SystemMay 27, 2022
K212054Senhance Surgical SystemAugust 30, 2021
K211325Senhance Surgical SystemJuly 27, 2021