ClearanceBrief
510(k) K131861 ยท NAY System, Surgical, Computer Controlled Instrument

DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIES

ApplicantIntuitive Surgical, Inc., Sunnyvale CA, US
DecisionSubstantially Equivalent, Mar 28, 2014
ReceivedJun 24, 2013
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K131861

DateFirm and productCodeLinked 510(k)
May 1, 2026Intuitive 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
NAYNone listed
Feb 2, 2026Intuitive 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
NAYNone listed
Jan 16, 2025Intuitive 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
NAYNone listed
Jan 16, 2025Intuitive 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
NAYNone listed
Jan 10, 2025Intuitive Surgical, Inc.
8MM, MONOPOLAR CURVED SCISSORS, IS4000 REF 470179
Open, Classified
NAYNone listed
Jan 10, 2025Intuitive Surgical, Inc.
8MM, POTTS SCISSORS, IS4000 REF 470001
Open, Classified
NAYNone listed
Jan 10, 2025Intuitive Surgical, Inc.
8MM, LARGE NEEDLE DRIVER, IS4000 REF 470006
Open, Classified
NAYNone listed
Jan 10, 2025Intuitive Surgical, Inc.
8MM,BLACK DIAMOND MICRO FORCEPS,IS4000 REF 470033
Open, Classified
NAYNone listed
Jan 10, 2025Intuitive Surgical, Inc.
8MM,PROGRASP FORCEPS,IS4000 REF 470093
Open, Classified
NAYNone listed
Jan 10, 2025Intuitive Surgical, Inc.
8MM,MICRO BIPOLAR FORCEPS,IS4000 REF 470171
Open, Classified
NAYNone listed
Jan 10, 2025Intuitive Surgical, Inc.
8MM,MARYLAND BIPOLAR FORCEPS,IS4000 REF 470172
Open, Classified
NAYNone listed
Jan 10, 2025Intuitive Surgical, Inc.
8MM,RESANO FORCEPS,IS4000 REF 470181
Open, Classified
NAYNone listed
Jan 10, 2025Intuitive Surgical, Inc.
8MM,FENESTRATED BIPOLAR FORCEPS,IS4000 REF 470205
Open, Classified
NAYNone listed
Jan 10, 2025Intuitive Surgical, Inc.
8MM,TENACULUM FORCEPS,IS4000 REF 470207
Open, Classified
NAYNone listed
Jan 10, 2025Intuitive Surgical, Inc.
8MM,LARGE HEM-O-LOK CLIP APPLIER,IS4000 REF 470230
Open, Classified
NAYNone listed
Jan 10, 2025Intuitive Surgical, Inc.
8MM,ATRIAL RETRACTOR SHORT RIGHT,IS4000 REF 470246
Open, Classified
NAYNone listed
Jan 10, 2025Intuitive Surgical, Inc.
8MM,DUAL BLADE RETRACTOR,IS4000 REF 470249
Open, Classified
NAYNone listed
Jan 10, 2025Intuitive Surgical, Inc.
8MM,MEGA SUTURECUT ND,IS4000 REF 470309
Open, Classified
NAYNone listed
Jan 10, 2025Intuitive Surgical, Inc.
8MM,SMALL GRASPING RETRACTOR,IS4000 REF 470318
Open, Classified
NAYNone listed
Jan 10, 2025Intuitive Surgical, Inc.
8MM,MEDIUM-LARGE CLIP APPLIER,IS4000 REF 470327
Open, Classified
NAYNone listed
Jan 10, 2025Intuitive Surgical, Inc.
8MM,CURVED BIPOLAR DISSECTOR,IS4000 REF 470344
Open, Classified
NAYNone listed
Jan 10, 2025Intuitive Surgical, Inc.
8MM,TIP-UP FENESTRATED GRASPER,IS4000 REF 470347
Open, Classified
NAYNone listed
Jan 10, 2025Intuitive Surgical, Inc.
8MM,LONG TIP FORCEPS,IS4000 REF 471048
Open, Classified
NAYNone listed
Jan 10, 2025Intuitive Surgical, Inc.
8MM,PROGRASP FORCEPS,IS4000 REF 471093
Open, Classified
NAYNone listed
Jan 10, 2025Intuitive Surgical, Inc.
8MM,MICRO BIPOLAR FORCEPS,IS4000 REF 471171
Open, Classified
NAYNone listed
Jan 10, 2025Intuitive Surgical, Inc.
8MM,MARYLAND BIPOLAR FORCEPS,IS4000 REF 471172
Open, Classified
NAYNone listed
Jan 10, 2025Intuitive Surgical, Inc.
8MM,FENESTRATED BIPOLAR FORCEPS,IS4000 REF 471205
Open, Classified
NAYNone listed
Jan 10, 2025Intuitive Surgical, Inc.
8MM,MEGA SUTURECUT ND,IS4000 REF 471309
Open, Classified
NAYNone listed
Jan 10, 2025Intuitive Surgical, Inc.
8MM,CURVED BIPOLAR DISSECTOR,IS4000 REF 471344
Open, Classified
NAYNone listed
Jun 30, 2023Intuitive Surgical, Inc.
da Vinci Xi/X Tip-Up Fenestrated Grasper, REF: 470347, VER: 12
Open, Classified
NAYNone listed
Mar 28, 2023Intuitive Surgical, Inc.
da Vinci Xi Surgical System Model IS4000 da Vinci X Surgical System Model IS4200
Open, Classified
NAYNone listed
Mar 16, 2023Intuitive 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
NAYNone listed
Oct 25, 2022Intuitive 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
NAYNone listed
Jul 1, 2022Intuitive 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
NAYNone listed
Sep 21, 2021Intuitive 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
NAYNone listed
Jul 26, 2019Intuitive 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
NAYNone listed
Jun 17, 2019Intuitive 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
NAYNone listed
Apr 11, 2019Intuitive 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
NAYNone listed
Dec 4, 2018Intuitive Surgical, Inc.
Da Vinci Xi/X EndoWrist Monopolar Curved scissors (MCS), model number 470179-19, UDI: (00) 886874112298
Terminated
NAYNone listed
Nov 21, 2018Intuitive Surgical, Inc.
da Vinci Xi Surgical System
Terminated
NAYNone listed
Aug 15, 2018Intuitive 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
NAYNone listed
Jul 16, 2018Intuitive 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
NAYNone listed
May 17, 2018Intuitive Surgical, Inc.
The da Vinci Xi Surgical System (IS4000) Model Name: IS4000, Endoscope Controller. Model Number: 372601-16.
Open, Classified
NAYNone listed
Jun 6, 2017Intuitive 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
NAYNone listed
Oct 26, 2016Intuitive 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
NAYNone listed
Mar 25, 2016Intuitive 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
NAYNone listed
Mar 16, 2016Intuitive 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
NAYNone listed
Feb 16, 2016Intuitive 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
NAYNone listed
Jan 14, 2016Intuitive 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
NAYNone listed
Jan 14, 2016Intuitive 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
NAYNone listed
Sep 3, 2015Intuitive 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
NAYNone listed
Jul 1, 2015Intuitive 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
NAYNone listed
Mar 20, 2015Intuitive 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
NAYNone listed
Mar 20, 2015Intuitive 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
NAYNone listed
Mar 20, 2015Intuitive 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
NAYNone listed
Nov 25, 2014Intuitive Surgical, Inc.
8MM,POTTS SCISSORS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Terminated
NAYNone listed
Nov 25, 2014Intuitive Surgical, Inc.
8MM,LARGE NEEDLE DRIVER; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Terminated
NAYNone listed
Nov 25, 2014Intuitive Surgical, Inc.
8MM,BLACK DIAMOND MICRO FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Terminated
NAYNone listed
Nov 25, 2014Intuitive Surgical, Inc.
8MM,LONG TIP FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Terminated
NAYNone listed
Nov 25, 2014Intuitive Surgical, Inc.
8MM,MICRO BIPOLAR FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Terminated
NAYNone listed
Nov 25, 2014Intuitive Surgical, Inc.
8MM,PROGRASP FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Terminated
NAYNone listed
Nov 25, 2014Intuitive Surgical, Inc.
8MM,MARYLAND BIPOLAR FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Terminated
NAYNone listed
Nov 25, 2014Intuitive Surgical, Inc.
8MM MONOPOLAR CURVED SCISSORS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Terminated
NAYNone listed
Nov 25, 2014Intuitive Surgical, Inc.
8MM RESANO FORCEPS,; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Terminated
NAYNone listed
Nov 25, 2014Intuitive Surgical, Inc.
8MM PERMANENT CAUTERY HOOK,; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Terminated
NAYNone listed
Nov 25, 2014Intuitive Surgical, Inc.
8MM PERMANENT CAUTERY SPATULA,; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Terminated
NAYNone listed
Nov 25, 2014Intuitive Surgical, Inc.
8MM FENESTRATED BIPOLAR FORCEPS,; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Terminated
NAYNone listed
Nov 25, 2014Intuitive Surgical, Inc.
8MM, TENACULUM FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Terminated
NAYNone listed
Nov 25, 2014Intuitive Surgical, Inc.
8MM, CARDIAC PROBE GRASPER; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Terminated
NAYNone listed
Nov 25, 2014Intuitive Surgical, Inc.
8MM, LARGE HEM-O-LOK CLIP APPLIER; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Terminated
NAYNone listed
Nov 25, 2014Intuitive Surgical, Inc.
8MM, ATRIAL RETRACTOR SHORT RIGHT ; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Terminated
NAYNone listed
Nov 25, 2014Intuitive Surgical, Inc.
8MM, DUAL BLADE RETRACTOR; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Terminated
NAYNone listed
Nov 25, 2014Intuitive Surgical, Inc.
8MM, MEGA SUTURECUT ND; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Terminated
NAYNone listed
Nov 25, 2014Intuitive Surgical, Inc.
8MM, SMALL GRASPING RETRACTOR ; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Terminated
NAYNone listed
Nov 25, 2014Intuitive Surgical, Inc.
8MM,MEDIUM-LARGE CLIP APPLIER ; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Terminated
NAYNone listed
Nov 25, 2014Intuitive Surgical, Inc.
8MM, CURVED BIPOLAR DISSECTOR; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Terminated
NAYNone listed
Nov 25, 2014Intuitive Surgical, Inc.
8MM, TIP-UP FENESTRATED GRASPER; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Terminated
NAYNone listed
Sep 30, 2014Intuitive 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
NAYNone listed
Jun 25, 2014Intuitive Surgical, Inc.
IS4000 da Vinci Xi - Endoscope accessory; 30 Degree, 8mm Endoscope. Intuitive Surgical Inc.
Terminated
NAYNone listed
Jun 4, 2014Intuitive 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
NAYNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.