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Sign in to claim this brandAsensus Surgical, Inc.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 1001 Hill Dr Ste 155, Durham, NC, 27703
- Website
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- —
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- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3039523130
- DUNS Number
- —
Catalogue (57)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Senhance | X9007013 | EUDAMEDFDA UDI | Class II | Active |
| Senhance | X0007003 | EUDAMEDFDA UDI | Class II | Active |
| Senhance | X9007003 | EUDAMEDFDA UDI | Class II | Active |
| Senhance | X9007019 | EUDAMEDFDA UDI | Class II | Active |
| Senhance | X9007016 | FDA UDI | Class II | Active |
| Senhance | X9007042 | FDA UDI | Class II | Active |
| Senhance | X0007303 | FDA UDI | Class II | Active |
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FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Sep 15, 2023 | Z-0170-2024 | — | terminated | Asensus Surgical has identified a malfunction that has occurred and may recur on the Senhance Surgical System. This issue presented itself as uncontrolled arm motion of the Laparoscope Instrument Actuator (LIA) where the LIA rotated continuously in one direction after the Surgeon removed the engagement of teleoperation on the Senhance System. There was no other uncontrolled arm motion observed. |