IS4000 da Vinci EndoWrist Instruments— 510(k) K150284
Substantially EquivalentIntuitive Surgical, Inc.
FDA 510(k) clearance K150284 for IS4000 da Vinci EndoWrist Instruments, Substantially Equivalent on 2015-05-15. 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
- Substantially Equivalent
- Clearance type
- Special
- 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 K150284
K-number listed on FDA's recall record- Z-0850-2025 — 8MM, ROUND TIP SCISSORS, IS4000 ¿ REF 470007
- Z-0852-2025 — 8MM,DEBAKEY FORCEPS,IS4000 ¿ REF 470036
- Z-0853-2025 — 8MM,CADIERE FORCEPS,IS4000 ¿ REF 470049
- Z-0858-2025 — 8MM,MEGA NEEDLE DRIVER,IS4000¿ REF 470194
- Z-0864-2025 — 8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000¿ REF 470296
- Z-0873-2025 — 8MM,CADIERE FORCEPS,IS4000 REF 471049
- Z-0877-2025 — 8MM,COBRA GRASPER,IS4000 REF 471190
- Z-0879-2025 — 8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000 REF 471296
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K150284.
Data sourced from openFDA. This site is unofficial and independent of the FDA.