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Panels › Gastroenterology, Urology › Product code NAY · Class 2

System, Surgical, Computer Controlled Instrument

Regulation 876.1500

9510(k)s in 12 months (166 all time)
16recalls in 12 months (248 all time)
244recalls that name a 510(k)
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Top companies in NAY

Company510(k)sRecalls
Intuitive Surgical147246
Transenterix, Inc.90
Asensus Surgical61
Aktormed GmbH20
Computer Motion, Inc.20
Olympus Corporation of the Americas01
DateFirm and productCodeLinked 510(k)
Jan 10, 2025Intuitive Surgical, Inc.
8MM,DEBAKEY FORCEPS,IS4000 REF 470036
Open, Classified		 NAYK150284
Jan 10, 2025Intuitive Surgical, Inc.
8MM,BLACK DIAMOND MICRO FORCEPS,IS4000 REF 470033
Open, Classified		 NAYK131861
Jan 10, 2025Intuitive Surgical, Inc.
8MM, ROUND TIP SCISSORS, IS4000 REF 470007
Open, Classified		 NAYK150284
Jan 10, 2025Intuitive Surgical, Inc.
8MM, LARGE NEEDLE DRIVER, IS4000 REF 470006
Open, Classified		 NAYK131861
Jan 10, 2025Intuitive Surgical, Inc.
8MM, POTTS SCISSORS, IS4000 REF 470001
Open, Classified		 NAYK131861
Jan 10, 2025Intuitive Surgical, Inc.
8MM, MONOPOLAR CURVED SCISSORS, IS4000 REF 470179
Open, Classified		 NAYK131861
K220023
Jun 28, 2024Olympus Corporation of the Americas
EasySuite 4K Integrated Operating Room System Model/Catalog Number: EasySuite 4K- The EasySuite 4K system includes a touch panel user interface for quick routing of 2K/4K procedural video to displays
Open, Classified		 NAYNone listed
Apr 11, 2024Intuitive Surgical, Inc.
Patient Cart, Part: 380601, a component of the da Vinci SP Surgical System, Model: SP1098
Open, Classified		 NAYK173906
K182371
Nov 28, 2023Intuitive Surgical, Inc.
Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm
Open, Classified		 NAYK152448
Oct 30, 2023Asensus Surgical Inc
Senhance Surgical System, which includes: Manipulator Arm, ISU Configuration ( Catalog Number X9007708), Intelligent Surgical Unit (Catalog Number X9007696), and Cockpit, ISU Configuration (Catalog Nu
Terminated		 NAYK223095
Jun 30, 2023Intuitive Surgical, Inc.
da Vinci Xi/X Tip-Up Fenestrated Grasper, REF: 470347, VER: 12
Open, Classified		 NAYK131861
Mar 28, 2023Intuitive Surgical, Inc.
da Vinci Xi Surgical System Model IS4000 da Vinci X Surgical System Model IS4200
Open, Classified		 NAYK131861
K171294
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		 NAYK131861
K171294
Nov 30, 2022Intuitive Surgical, Inc.
INTUITIVE Da Vinci Xi 8mm SureForm 30 Curved-Tip Stapler Da Vinci Xi|X REF 488530 INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm Gray 4-Row 2.0 mm Xi|X REF 48230M INTUITIVE Da Vinci 8mm SureForm 3
Open, Classified		 NAYK211997
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		 NAYK131861
K171294
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		 NAYK131861
K150837
Jul 1, 2022Intuitive Surgical, Inc.
Da Vinci S/Si Large Clip Applier, Model 420230 Da Vinci S/Si Medium-Large Clip Applier, Model 420327 Da Vinci S/Si Small Clip Applier, Model 420003
Open, Classified		 NAYK050369
Jun 22, 2022Intuitive Surgical, Inc.
The E-100 Generator (PN 374848-09) is a bipolar electrosurgical unit (ESU) designed to be used with the da Vinci Xi and X systems. The E-100 is installed on the Vision Cart and is connected to the sys
Completed		 NAYK191280
Apr 22, 2022Intuitive Surgical, Inc.
da Vinici X da Vinci Xi Sureform 45 REF 480445 da Vinci X da Vinci Xi Sureform 45 Curved-Tip REF 480545 da Vinici X da Vinci Xi Sureform 60 REF 480460
Open, Classified		 NAYK173721
K183224 +1
Mar 3, 2022Intuitive Surgical, Inc.
VESSEL SEALER EXTEND, Single-Use Instrument EndoWrist Instruments 8mm, da Vinci X' da Vinci Xi', REF 480422
Completed		 NAYK173337
Dec 23, 2021Intuitive Surgical, Inc.
da Vinci Xi and X 12-8 mm Conductive Cannula Reducer, REF: 470381-11
Open, Classified		 NAYK140553
K162411
Sep 22, 2021Intuitive Surgical, Inc.
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
Open, Classified		 NAYK173906
K182371 +4
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		 NAYK131861
Jun 3, 2020Intuitive Surgical, Inc.
da Vinci SP surgical system
Terminated		 NAYK173906
Aug 19, 2019Intuitive Surgical, Inc.
da Vinci SP Camera; PN 430060-33; Model Number: 430060-33. For endoscopic surgery.
Open, Classified		 NAYK173906
Jul 26, 2019Intuitive Surgical, Inc.
da Vinci SP Surgical System, SP1098, 00886874114605 Product Usage: used with an endoscope, surgical instruments, and accessories to perform minimally invasive surgical procedures.
Terminated		 NAYK173906
Jul 26, 2019Intuitive Surgical, Inc.
da Vinci X Surgical System Surgical System, IS4200, 00886874114216 Product Usage: used with an endoscope, surgical instruments, and accessories to perform minimally invasive surgical procedures.
Terminated		 NAYK171294
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		 NAYK131861
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		 NAYK131861
Apr 11, 2019Intuitive Surgical Inc
da Vinci X Surgical System, IS4200 - 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		 NAYK171294
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		 NAYK131861
Jan 16, 2019Intuitive Surgical, Inc.
daVinci Harmonic ACE Curved Shears
Open, Classified		 NAYK093217
K112584
Dec 4, 2018Intuitive Surgical, Inc.
Da Vinci Xi/X EndoWrist Monopolar Curved scissors (MCS), model number 470179-19, UDI: (00) 886874112298
Terminated		 NAYK131861
Nov 21, 2018Intuitive Surgical, Inc.
da Vinci X Surgical System
Terminated		 NAYK171294
Nov 21, 2018Intuitive Surgical, Inc.
da Vinci Xi Surgical System
Terminated		 NAYK131861
Oct 25, 2018Intuitive Surgical, Inc.
da Vinci SP Instrument Arm Drape. REF 430013-12 QTY 1 Pouch
Terminated		 NAYK173906
Oct 23, 2018Intuitive Surgical, Inc.
The da Vinci SP surgical system is made of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The Patient Cart is the operative component of the SP syste
Terminated		 NAYK173906
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		 NAYK131861
Aug 15, 2018Intuitive Surgical, Inc.
da Vinci S/Si EndoWrist 8mm Monopolar Curved Scissors Model No. 420179-16 Product Usage: EndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and electrocautery are intended f
Open, Classified		 NAYK050369
K180033
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		 NAYK081137
K131861 +1
Jun 4, 2018Intuitive Surgical, Inc.
EndoWrist Suction Irrigator, Single Use Instrument. Part Number: 480299-04. An accessory to the EndoWrist Surgical System, used in endoscopic surgery.
Open, Classified		 NAYK162973
May 17, 2018Intuitive Surgical, Inc.
The da Vinci Xi Surgical System (IS4000) Model Name: IS4000, Endoscope Controller. Model Number: 372601-16.
Open, Classified		 NAYK131861
Mar 7, 2018Intuitive Surgical, Inc.
da Vinci X Surgical System, Model IS4200. Product Usage: The Intuitive Surgical Endoscopic Instrument Control System (da Vinci X Surgical System Mode IS4200) is intended to assist in the accurate con
Terminated		 NAYK171294
Sep 19, 2017Intuitive Surgical, Inc.
daVinci X EndoWrist(R) Stapler 45, REF 470298 Product Usage: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads, and other Stapler Accessories (including the bladeless obturators) are in
Terminated		 NAYK140553
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		 NAYK131861
Apr 13, 2017Intuitive Surgical, Inc.
da Vinci Xi EndoWrist Suction Irrigator, 8 mm instrument; PN 480299-03; and SOFTWARE, EMBEDDED RLS, IS4000, A70_P6_B440; PN 610092-440. General and Plastic Surgery: The EndoWrist Suction Irrigator
Terminated		 NAYK162973
Mar 15, 2017Intuitive Surgical, Inc.
STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi Turkish SRK General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Relo
Terminated		 NAYK140553
Mar 15, 2017Intuitive Surgical, Inc.
STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi Spanish SRK General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Relo
Terminated		 NAYK140553
Mar 15, 2017Intuitive Surgical, Inc.
STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi Swedish SRK General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloa
Terminated		 NAYK140553
Mar 15, 2017Intuitive Surgical, Inc.
STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi Portuguese SRK General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 R
Terminated		 NAYK140553

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