Asensus Surgical Inc
FDA Regulatory Profile
Asensus Surgical Inc appears in FDA public data with 1 recall — including 1 Class I (most serious) —, 6 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0170-2024, Class I) was initiated on September 15, 2023. Its most recent 510(k) clearance was granted on May 12, 2026.
Summary
- Total Recalls
- 1 (1 Class I)
- 510(k) Clearances
- 6
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0170-2024 | Class I | Senhance Surgical System, which includes: Manipulator Arm, ISU Configuration ( Catalog Number X90077 | September 15, 2023 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K254192 | Senhance Ultrasonic System | May 12, 2026 |
| K233866 | Senhance Surgical System | July 19, 2024 |
| K223095 | Senhance Surgical System | March 16, 2023 |
| K220889 | Senhance Surgical System | May 27, 2022 |
| K212054 | Senhance Surgical System | August 30, 2021 |
| K211325 | Senhance Surgical System | July 27, 2021 |