Asensus Surgical, Inc.
Medical device manufacturer in Durham, NC.
6510(k) clearances
0PMA approvals
1recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K254192 | Senhance Ultrasonic SystemNAY · Traditional | 05/12/2026SE |
| K233866 | Senhance Surgical SystemNAY · Traditional | 07/19/2024SE |
| K223095 | Senhance Surgical SystemNAY · Traditional | 03/16/2023SE |
| K220889 | Senhance Surgical SystemNAY · Special | 05/27/2022SE |
| K212054 | Senhance Surgical SystemNAY · Traditional | 08/30/2021SE |
| K211325 | Senhance Surgical SystemNAY · Traditional | 07/27/2021SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0170-2024 Class I | Senhance Surgical System, which includes: Manipulator Arm, ISU Configuration ( Catalog…Asensus Surgical has identified a malfunction that has occurred and may recur on the Senhance Surgical… | 09/15/2023Terminated |