Asensus Surgical Inc

FDA Regulatory Profile

Summary

Total Recalls
1 (1 Class I)
510(k) Clearances
6
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
K254192Senhance Ultrasonic SystemMay 12, 2026
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