da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories— 510(k) K182371
UnknownIntuitive Surgical, Inc.
FDA 510(k) clearance K182371 for da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories, Unknown on 2019-03-14. Applicant: Intuitive Surgical, Inc.. Device class: 2.
Clearance details
- Applicant
- Intuitive Surgical, Inc.
- Product code
- Code NAY
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Traditional
- Location
- Sunnyvale, CA, US
Recent devices under product code NAY
view allMore clearances from Intuitive Surgical, Inc.
view allAdverse events under product code NAY
product code NAY- Death
- 433
- Injury
- 7,927
- Malfunction
- 93,790
- Other
- 19
- Total
- 102,169
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K182371
K-number listed on FDA's recall record- Z-2521-2026 — Da Vinci ASSY, PSS, SP1098, Part Number: 380601
- Z-1518-2024 — Patient Cart, Part: 380601, a component of the da Vinci SP Surgical System, Model: SP1098
- Z-0419-2022 — 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/ 380941-44 / 00886874114742 SOFTWARE, SYSTEM EMBEDDED RLS, SP1098, B70_P4_B327 (OS4 v4.0.0 (P4_B327) / 610112-327 / N/A
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K182371.
Data sourced from openFDA. This site is unofficial and independent of the FDA.