510(k) K211595 ยท NAY System, Surgical, Computer Controlled Instrument
da Vinci SP Surgical System (SP1098)
| Applicant | Intuitive Surgical, Inc., Sunnyvale CA, US |
| Decision | Unknown, Jun 23, 2021 |
| Received | May 24, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K211595
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 22, 2021 | Intuitive Surgical, Inc. da Vinci SP Surgical systems with the following Model Name/ Model Number / UDI:
ASSY,PSS,SP1098,P4/ 380601-44/ 00886874114605
ASSY,SSC,SP1098,P4/ 380940-44 / 00886874114735
ASSY,VSS,SP1098,P4/ 380941 Open, Classified |
NAY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.