510(k) K131861 ยท NAY System, Surgical, Computer Controlled Instrument
DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIES
| Applicant | Intuitive Surgical, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Mar 28, 2014 |
| Received | Jun 24, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131861
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 1, 2026 | Intuitive Surgical, Inc. 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 Open, Classified |
NAY | None listed |
| Feb 2, 2026 | Intuitive Surgical, Inc. 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 Open, Classified |
NAY | None listed |
| Jan 16, 2025 | Intuitive Surgical, Inc. 8MM, Tenaculum Forceps REF 470207
Instrument used with the da Vinci X/Xi Surgical Systems in a wide variety of procedures to perform a variety of surgical tasks including manipulation and retraction Open, Classified |
NAY | None listed |
| Jan 16, 2025 | Intuitive Surgical, Inc. 8MM, Small Graptor REF 470318
Is a grasping retractor Instrument used with the da Vinci X/Xi Surgical Systems in a wide variety of procedures to perform a variety of surgical tasks including manipula Open, Classified |
NAY | None listed |
| Jan 10, 2025 | Intuitive Surgical, Inc. 8MM, MONOPOLAR CURVED SCISSORS, IS4000 REF 470179 Open, Classified |
NAY | None listed |
| Jan 10, 2025 | Intuitive Surgical, Inc. 8MM, POTTS SCISSORS, IS4000 REF 470001 Open, Classified |
NAY | None listed |
| Jan 10, 2025 | Intuitive Surgical, Inc. 8MM, LARGE NEEDLE DRIVER, IS4000 REF 470006 Open, Classified |
NAY | None listed |
| Jan 10, 2025 | Intuitive Surgical, Inc. 8MM,BLACK DIAMOND MICRO FORCEPS,IS4000 REF 470033 Open, Classified |
NAY | None listed |
| Jan 10, 2025 | Intuitive Surgical, Inc. 8MM,PROGRASP FORCEPS,IS4000 REF 470093 Open, Classified |
NAY | None listed |
| Jan 10, 2025 | Intuitive Surgical, Inc. 8MM,MICRO BIPOLAR FORCEPS,IS4000 REF 470171 Open, Classified |
NAY | None listed |
| Jan 10, 2025 | Intuitive Surgical, Inc. 8MM,MARYLAND BIPOLAR FORCEPS,IS4000 REF 470172 Open, Classified |
NAY | None listed |
| Jan 10, 2025 | Intuitive Surgical, Inc. 8MM,RESANO FORCEPS,IS4000 REF 470181 Open, Classified |
NAY | None listed |
| Jan 10, 2025 | Intuitive Surgical, Inc. 8MM,FENESTRATED BIPOLAR FORCEPS,IS4000 REF 470205 Open, Classified |
NAY | None listed |
| Jan 10, 2025 | Intuitive Surgical, Inc. 8MM,TENACULUM FORCEPS,IS4000 REF 470207 Open, Classified |
NAY | None listed |
| Jan 10, 2025 | Intuitive Surgical, Inc. 8MM,LARGE HEM-O-LOK CLIP APPLIER,IS4000 REF 470230 Open, Classified |
NAY | None listed |
| Jan 10, 2025 | Intuitive Surgical, Inc. 8MM,ATRIAL RETRACTOR SHORT RIGHT,IS4000 REF 470246 Open, Classified |
NAY | None listed |
| Jan 10, 2025 | Intuitive Surgical, Inc. 8MM,DUAL BLADE RETRACTOR,IS4000 REF 470249 Open, Classified |
NAY | None listed |
| Jan 10, 2025 | Intuitive Surgical, Inc. 8MM,MEGA SUTURECUT ND,IS4000 REF 470309 Open, Classified |
NAY | None listed |
| Jan 10, 2025 | Intuitive Surgical, Inc. 8MM,SMALL GRASPING RETRACTOR,IS4000 REF 470318 Open, Classified |
NAY | None listed |
| Jan 10, 2025 | Intuitive Surgical, Inc. 8MM,MEDIUM-LARGE CLIP APPLIER,IS4000 REF 470327 Open, Classified |
NAY | None listed |
| Jan 10, 2025 | Intuitive Surgical, Inc. 8MM,CURVED BIPOLAR DISSECTOR,IS4000 REF 470344 Open, Classified |
NAY | None listed |
| Jan 10, 2025 | Intuitive Surgical, Inc. 8MM,TIP-UP FENESTRATED GRASPER,IS4000 REF 470347 Open, Classified |
NAY | None listed |
| Jan 10, 2025 | Intuitive Surgical, Inc. 8MM,LONG TIP FORCEPS,IS4000 REF 471048 Open, Classified |
NAY | None listed |
| Jan 10, 2025 | Intuitive Surgical, Inc. 8MM,PROGRASP FORCEPS,IS4000 REF 471093 Open, Classified |
NAY | None listed |
| Jan 10, 2025 | Intuitive Surgical, Inc. 8MM,MICRO BIPOLAR FORCEPS,IS4000 REF 471171 Open, Classified |
NAY | None listed |
| Jan 10, 2025 | Intuitive Surgical, Inc. 8MM,MARYLAND BIPOLAR FORCEPS,IS4000 REF 471172 Open, Classified |
NAY | None listed |
| Jan 10, 2025 | Intuitive Surgical, Inc. 8MM,FENESTRATED BIPOLAR FORCEPS,IS4000 REF 471205 Open, Classified |
NAY | None listed |
| Jan 10, 2025 | Intuitive Surgical, Inc. 8MM,MEGA SUTURECUT ND,IS4000 REF 471309 Open, Classified |
NAY | None listed |
| Jan 10, 2025 | Intuitive Surgical, Inc. 8MM,CURVED BIPOLAR DISSECTOR,IS4000 REF 471344 Open, Classified |
NAY | None listed |
| Jun 30, 2023 | Intuitive Surgical, Inc. da Vinci Xi/X Tip-Up Fenestrated Grasper, REF: 470347, VER: 12 Open, Classified |
NAY | None listed |
| Mar 28, 2023 | Intuitive Surgical, Inc. da Vinci Xi Surgical System Model IS4000
da Vinci X Surgical System Model IS4200 Open, Classified |
NAY | None listed |
| Mar 16, 2023 | Intuitive Surgical, Inc. Patient Side Cart, REF: 380620, with instrument arms, used as part of the da Vinci X Surgical System, REF: IS4200;
Patient Side Cart, REF: 380652, with instrument arms, used as part of the da Vinci X Open, Classified |
NAY | None listed |
| Oct 25, 2022 | Intuitive Surgical, Inc. da Vinci X (IS4200) and Xi (IS4000) systems, which consists of finished devices Surgeon Console (SSC), Patient Cart (PSCART), Vision System (VSS) Open, Classified |
NAY | None listed |
| Jul 1, 2022 | Intuitive Surgical, Inc. Da Vinci X/Xi Large Clip Applier, Model 470230
Da Vinci X/Xi Medium-Large Clip Applier, Model 470327
Da Vinci X/Xi Small Clip Applier, Model 47401 Open, Classified |
NAY | None listed |
| Sep 21, 2021 | Intuitive Surgical, Inc. The da Vinci Xi and X surgical systems (IS4000 and IS4200) each consist of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The Patient Cart is the ope Terminated |
NAY | None listed |
| Jul 26, 2019 | Intuitive Surgical, Inc. da Vinci Xi Surgical System Surgical System, IS4000, 00886874114216 - Product Usage: used with an endoscope, surgical instruments, and accessories to perform minimally invasive surgical procedures. Terminated |
NAY | None listed |
| Jun 17, 2019 | Intuitive Surgical, Inc. da Vinci Surgical System, IS 4000; Endoscope Controller, Model Number: 372601-16 (UDI: 00886874114193) is included in the IS 4000 Vision Cart, Model Number: 381121-31 (UDI 00886874110898) - Product Us Terminated |
NAY | None listed |
| Apr 11, 2019 | Intuitive Surgical Inc da Vinci Xi Surgical System, IS4000 - Product Usage: The da Vinci Xi surgical system (IS4000) is made of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC Terminated |
NAY | None listed |
| Dec 4, 2018 | Intuitive Surgical, Inc. Da Vinci Xi/X EndoWrist Monopolar Curved scissors (MCS), model number 470179-19, UDI: (00) 886874112298 Terminated |
NAY | None listed |
| Nov 21, 2018 | Intuitive Surgical, Inc. da Vinci Xi Surgical System Terminated |
NAY | None listed |
| Aug 15, 2018 | Intuitive Surgical, Inc. da Vinci X/Xi EndoWrist 8mm Monopolar Curved Scissors Model No. 470179-14
Product Usage:
EndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and electrocautery are intended f Open, Classified |
NAY | None listed |
| Jul 16, 2018 | Intuitive Surgical, Inc. da Vinci Si/X/Xi Surgical System Redundant Medical Grade Power Supply (RMGPS) Units
The da Vinci System consists of a Surgeon Console, a Patient Cart, and a Vision Cart and is used with an endoscope Terminated |
NAY | None listed |
| May 17, 2018 | Intuitive Surgical, Inc. The da Vinci Xi Surgical System (IS4000) Model Name: IS4000, Endoscope Controller.
Model Number:
372601-16. Open, Classified |
NAY | None listed |
| Jun 6, 2017 | Intuitive Surgical, Inc. da Vinci Xi Surgical System
Product Usage:
The da Vinci Xi Surgical System (IS4000) is designed to assist a surgeon in the accurate control of surgical instruments such as endoscopes, scissors, fo Terminated |
NAY | None listed |
| Oct 26, 2016 | Intuitive Surgical, Inc. da Vinci Xi" Surgical System, model number IS4000, A70_P5x with P5 Software;
General and Plastic Surgery:
The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model I Terminated |
NAY | None listed |
| Mar 25, 2016 | Intuitive Surgical, Inc. EndoWrist Stapler 45 and Stapler 30 instruments used on the da Vinci Xi systems (IS4000) with p5 software.
General Surgery: The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surg Terminated |
NAY | None listed |
| Mar 16, 2016 | Intuitive Surgical, Inc. da Vinci S Surgical System (IS4000) user manual English and OUS.
Product Usage:
The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assi Terminated |
NAY | None listed |
| Feb 16, 2016 | Intuitive Surgical, Inc. da Vinci Si (IS3000) and da Vinci Xi (IS4000) Surgeon Side Console (SSC)Touchpad; Model number 187505-04; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. The s Terminated |
NAY | None listed |
| Jan 14, 2016 | Intuitive Surgical, Inc. 0 deg, 8mm Endoscope, IS4000:
Model numbers: 470026-34, 470026-40, 470026-41.
General and Plastic Surgery:
The da Vinci Xi endoscope produces high definition (HD), visible light (VIS). The HD video i Terminated |
NAY | None listed |
| Jan 14, 2016 | Intuitive Surgical, Inc. 30 deg, 8mm Endoscope, IS4000:
Model numbers: 470027-34, 470027-40, 470027-41.
General and Plastic Surgery:
The da Vinci Xi endoscope produces high definition (HD), visible light (VIS). The HD video Terminated |
NAY | None listed |
| Sep 3, 2015 | Intuitive Surgical, Inc. da Vinci Xi Surgical System P4 software;with Xi Stapler; model number IS4000 :
General and Plastic surgery:
The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Mode Terminated |
NAY | None listed |
| Jul 1, 2015 | Intuitive Surgical, Inc. INSTRUMENT ARM DRAPE, IS4000, 20 PACK; used on the da Vinci Xi Surgical System.
The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assi Terminated |
NAY | None listed |
| Mar 20, 2015 | Intuitive Surgical, Inc. da Vinci Xi Surgical System, IS4000;
Assy, Distal SUJ, Inner, IS4000
Material number: 380662-20 and 380662-21.
The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, M Terminated |
NAY | None listed |
| Mar 20, 2015 | Intuitive Surgical, Inc. da Vinci Xi Surgical System, IS4000;
ASSY,DISTAL SUJ,OUTER,IS4000,
Material number: 380663-20 and 380663-21.
The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Mod Terminated |
NAY | None listed |
| Mar 20, 2015 | Intuitive Surgical, Inc. da Vinci Xi Surgical System, IS4000;
ASSY,USM,IS4000,
Material number: 380647-20 and 380647-22
The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is i Terminated |
NAY | None listed |
| Nov 25, 2014 | Intuitive Surgical, Inc. 8MM,POTTS SCISSORS;
Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. Terminated |
NAY | None listed |
| Nov 25, 2014 | Intuitive Surgical, Inc. 8MM,LARGE NEEDLE DRIVER;
Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. Terminated |
NAY | None listed |
| Nov 25, 2014 | Intuitive Surgical, Inc. 8MM,BLACK DIAMOND MICRO FORCEPS;
Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. Terminated |
NAY | None listed |
| Nov 25, 2014 | Intuitive Surgical, Inc. 8MM,LONG TIP FORCEPS;
Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. Terminated |
NAY | None listed |
| Nov 25, 2014 | Intuitive Surgical, Inc. 8MM,MICRO BIPOLAR FORCEPS;
Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. Terminated |
NAY | None listed |
| Nov 25, 2014 | Intuitive Surgical, Inc. 8MM,PROGRASP FORCEPS;
Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. Terminated |
NAY | None listed |
| Nov 25, 2014 | Intuitive Surgical, Inc. 8MM,MARYLAND BIPOLAR FORCEPS;
Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. Terminated |
NAY | None listed |
| Nov 25, 2014 | Intuitive Surgical, Inc. 8MM MONOPOLAR CURVED SCISSORS;
Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. Terminated |
NAY | None listed |
| Nov 25, 2014 | Intuitive Surgical, Inc. 8MM RESANO FORCEPS,;
Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. Terminated |
NAY | None listed |
| Nov 25, 2014 | Intuitive Surgical, Inc. 8MM PERMANENT CAUTERY HOOK,;
Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. Terminated |
NAY | None listed |
| Nov 25, 2014 | Intuitive Surgical, Inc. 8MM PERMANENT CAUTERY SPATULA,;
Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. Terminated |
NAY | None listed |
| Nov 25, 2014 | Intuitive Surgical, Inc. 8MM FENESTRATED BIPOLAR FORCEPS,;
Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. Terminated |
NAY | None listed |
| Nov 25, 2014 | Intuitive Surgical, Inc. 8MM, TENACULUM FORCEPS;
Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. Terminated |
NAY | None listed |
| Nov 25, 2014 | Intuitive Surgical, Inc. 8MM, CARDIAC PROBE GRASPER;
Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. Terminated |
NAY | None listed |
| Nov 25, 2014 | Intuitive Surgical, Inc. 8MM, LARGE HEM-O-LOK CLIP APPLIER;
Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. Terminated |
NAY | None listed |
| Nov 25, 2014 | Intuitive Surgical, Inc. 8MM, ATRIAL RETRACTOR SHORT RIGHT ;
Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. Terminated |
NAY | None listed |
| Nov 25, 2014 | Intuitive Surgical, Inc. 8MM, DUAL BLADE RETRACTOR;
Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. Terminated |
NAY | None listed |
| Nov 25, 2014 | Intuitive Surgical, Inc. 8MM, MEGA SUTURECUT ND;
Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. Terminated |
NAY | None listed |
| Nov 25, 2014 | Intuitive Surgical, Inc. 8MM, SMALL GRASPING RETRACTOR ;
Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. Terminated |
NAY | None listed |
| Nov 25, 2014 | Intuitive Surgical, Inc. 8MM,MEDIUM-LARGE CLIP APPLIER ;
Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. Terminated |
NAY | None listed |
| Nov 25, 2014 | Intuitive Surgical, Inc. 8MM, CURVED BIPOLAR DISSECTOR;
Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. Terminated |
NAY | None listed |
| Nov 25, 2014 | Intuitive Surgical, Inc. 8MM, TIP-UP FENESTRATED GRASPER;
Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. Terminated |
NAY | None listed |
| Sep 30, 2014 | Intuitive Surgical, Inc. ASSEMBLY, PATIENT SIDE CART, PS4000 used with the da Vinci Xi Surgical System.
Product Usage: The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is i Terminated |
NAY | None listed |
| Jun 25, 2014 | Intuitive Surgical, Inc. IS4000 da Vinci Xi - Endoscope accessory;
30 Degree, 8mm Endoscope.
Intuitive Surgical Inc. Terminated |
NAY | None listed |
| Jun 4, 2014 | Intuitive Surgical, Inc. Patient Side Cart assembly, 4-arm, for use with Intuitive Surgical, Inc. da Vinci Surgical System IS 4000. The patient-side cart is positioned at the operating room table and contains four arms that Terminated |
NAY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.