510(k) K202571 ยท NAY System, Surgical, Computer Controlled Instrument
da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments, and Accessories
| Applicant | Intuitive Surgical, Inc., Sunnyvale CA, US |
| Decision | Unknown, Nov 12, 2020 |
| Received | Sep 4, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K202571
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 15, 2026 | Intuitive Surgical, Inc. da Vinci SP, SP Access Port Kit, Large Incision
Reference Numbers:430073 (2.7-4cm,SP1098, Box) & 430075 (2.7-7cm,SP1098,Box) Open, Classified |
NAY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.