510(k) K223095 ยท NAY System, Surgical, Computer Controlled Instrument
Senhance Surgical System
| Applicant | Asensus Surgical, Inc., Durham NC, US |
| Decision | Substantially Equivalent, Mar 16, 2023 |
| Received | Sep 30, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223095
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 30, 2023 | Asensus Surgical Inc Senhance Surgical System, which includes: Manipulator Arm, ISU Configuration ( Catalog Number X9007708), Intelligent Surgical Unit (Catalog Number X9007696), and Cockpit, ISU Configuration (Catalog Nu Terminated |
NAY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.