510(k) K182371 ยท NAY System, Surgical, Computer Controlled Instrument
da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories
| Applicant | Intuitive Surgical, Inc., Sunnyvale CA, US |
| Decision | Unknown, Mar 14, 2019 |
| Received | Aug 31, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182371
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 10, 2026 | Intuitive Surgical, Inc. da Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15 Open, Classified |
NAY | None listed |
| Jun 22, 2026 | Intuitive Surgical, Inc. Da Vinci ASSY, PSS, SP1098, Part Number: 380601 Open, Classified |
NAY | None listed |
| Apr 11, 2024 | Intuitive Surgical, Inc. Patient Cart, Part: 380601, a component of the da Vinci SP Surgical System, Model: SP1098 Open, Classified |
NAY | None listed |
| 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.