DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIES— 510(k) K131861
Substantially EquivalentIntuitive Surgical, Inc.
FDA 510(k) clearance K131861 for DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIES, Substantially Equivalent on 2014-03-28. 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
- 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 K131861
K-number listed on FDA's recall record- Z-2046-2026 — Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical System Model/Catalog Number: IS4000; IS4200 Software Version: N/A Product Description: he da Vinci Xi, X Surgical systems each consist of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The PC is the operative component of the system, and its primary function is to support the instrument arms and camera arm. Each system have four Universal Surgical Manipulators (USMs) also known as arms, which allow the surgeon to control up to three instruments and an endoscope simultaneously to perform surgical tasks (e.g. cutting, suturing, tissue approximation) in a variety of procedures. As the surgeon moves the hand controls within the console, the PC moves the robotic instruments within the patient in a corresponding manner. The da Vinci system and its software are designed such that instruments motion precisely tracks the motion inputs from the hand controls during surgery. Component: The affected part based on this recall, 380647-xx, USM, is a sub component of da Vinci Surgical Instrument
- Z-1232-2026 — Brand Name: Da Vinci Product Name: da Vinci X, Xi Surgical System, & da Vinci 5 Surgical System Model/Catalog Number: IS4000; IS4200; IS5000 Software Version: N/A Product Description: The da Vinci Xi, X, and da Vinci 5 surgical systems each consist of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The PC is the operative component of the system, and its primary function is to support the instrument arms and camera arm. Each system have four Universal Surgical Manipulators (USMs) also known as arms, which allow the surgeon to control up to three instruments and an endoscope simultaneously to perform surgical tasks (e.g. cutting, suturing, tissue approximation) in a variety of procedures. As the surgeon moves the hand controls within the console, the PC moves the robotic instruments within the patient in a corresponding manner. The da Vinci system and its software are designed such that instruments motion precisely tracks the motion inputs from the hand controls during surgery. Component: The affected part based on this recall, 380647-xx, USM, is a sub component of da Vinci Surgical Instrument
- Z-0847-2025 — 8MM, MONOPOLAR CURVED SCISSORS, IS4000 REF 470179
- Z-0848-2025 — 8MM, POTTS SCISSORS, IS4000 REF 470001
- Z-0849-2025 — 8MM, LARGE NEEDLE DRIVER, IS4000 REF 470006
- Z-0851-2025 — 8MM,BLACK DIAMOND MICRO FORCEPS,IS4000 ¿ REF 470033
- Z-0854-2025 — 8MM,PROGRASP FORCEPS,IS4000 ¿ REF 470093
- Z-0855-2025 — 8MM,MICRO BIPOLAR FORCEPS,IS4000 ¿ REF 470171
- Z-0856-2025 — 8MM,MARYLAND BIPOLAR FORCEPS,IS4000 ¿ REF 470172
- Z-0857-2025 — 8MM,RESANO FORCEPS,IS4000 ¿ REF 470181
- Z-0859-2025 — 8MM,FENESTRATED BIPOLAR FORCEPS,IS4000¿ REF 470205
- Z-0860-2025 — 8MM,TENACULUM FORCEPS,IS4000¿ REF 470207
- Z-0861-2025 — 8MM,LARGE HEM-O-LOK CLIP APPLIER,IS4000¿ REF 470230
- Z-0862-2025 — 8MM,ATRIAL RETRACTOR SHORT RIGHT,IS4000¿ REF 470246
- Z-0863-2025 — 8MM,DUAL BLADE RETRACTOR,IS4000¿ REF 470249
- Z-0865-2025 — 8MM,MEGA SUTURECUT ND,IS4000¿ REF 470309
- Z-0866-2025 — 8MM,SMALL GRASPING RETRACTOR,IS4000¿ REF 470318
- Z-0867-2025 — 8MM,MEDIUM-LARGE CLIP APPLIER,IS4000¿ REF 470327
- Z-0868-2025 — 8MM,CURVED BIPOLAR DISSECTOR,IS4000¿ REF 470344
- Z-0869-2025 — 8MM,TIP-UP FENESTRATED GRASPER,IS4000¿ REF 470347
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K131861.
Data sourced from openFDA. This site is unofficial and independent of the FDA.