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

System, Surgical, Computer Controlled Instrument

Regulation 876.1500

10510(k)s in 12 months (167 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 Surgical148246
Transenterix, Inc.90
Asensus Surgical61
Aktormed GmbH20
Computer Motion, Inc.20
Olympus Corporation of the Americas01
DateFirm and productCodeLinked 510(k)
Nov 25, 2014Intuitive Surgical, Inc.
8MM, CURVED BIPOLAR DISSECTOR; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Terminated		 NAYK131861
Nov 25, 2014Intuitive Surgical, Inc.
8MM,MEDIUM-LARGE CLIP APPLIER ; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Terminated		 NAYK131861
Nov 25, 2014Intuitive Surgical, Inc.
8MM, SMALL GRASPING RETRACTOR ; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Terminated		 NAYK131861
Nov 25, 2014Intuitive Surgical, Inc.
8MM, MEGA SUTURECUT ND; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Terminated		 NAYK131861
Nov 25, 2014Intuitive Surgical, Inc.
8MM, DUAL BLADE RETRACTOR; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Terminated		 NAYK131861
Nov 25, 2014Intuitive Surgical, Inc.
8MM, ATRIAL RETRACTOR SHORT RIGHT ; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Terminated		 NAYK131861
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		 NAYK131861
Nov 25, 2014Intuitive Surgical, Inc.
8MM, CARDIAC PROBE GRASPER; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Terminated		 NAYK131861
Nov 25, 2014Intuitive Surgical, Inc.
8MM, TENACULUM FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Terminated		 NAYK131861
Nov 25, 2014Intuitive Surgical, Inc.
8MM FENESTRATED BIPOLAR FORCEPS,; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Terminated		 NAYK131861
Nov 25, 2014Intuitive Surgical, Inc.
8MM PERMANENT CAUTERY SPATULA,; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Terminated		 NAYK131861
Nov 25, 2014Intuitive Surgical, Inc.
8MM PERMANENT CAUTERY HOOK,; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Terminated		 NAYK131861
Nov 25, 2014Intuitive Surgical, Inc.
8MM RESANO FORCEPS,; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Terminated		 NAYK131861
Nov 25, 2014Intuitive Surgical, Inc.
8MM MONOPOLAR CURVED SCISSORS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Terminated		 NAYK131861
Nov 25, 2014Intuitive Surgical, Inc.
8MM,MARYLAND BIPOLAR FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Terminated		 NAYK131861
Nov 25, 2014Intuitive Surgical, Inc.
8MM,PROGRASP FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Terminated		 NAYK131861
Nov 25, 2014Intuitive Surgical, Inc.
8MM,MICRO BIPOLAR FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Terminated		 NAYK131861
Nov 25, 2014Intuitive Surgical, Inc.
8MM,LONG TIP FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Terminated		 NAYK131861
Nov 25, 2014Intuitive Surgical, Inc.
8MM,BLACK DIAMOND MICRO FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Terminated		 NAYK131861
Nov 25, 2014Intuitive Surgical, Inc.
8MM,LARGE NEEDLE DRIVER; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Terminated		 NAYK131861
Nov 25, 2014Intuitive Surgical, Inc.
8MM,POTTS SCISSORS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Terminated		 NAYK131861
Oct 16, 2014Intuitive Surgical, Inc.
EndoWrist Stapler 45 instrument for the da Vinci Si System Model Number: IS3000 Product Usage: For use with da Vinci Si System. The Intuitive Surgical Endoscopic Instrument Control System is inte
Terminated		 NAYK123463
Oct 10, 2014Intuitive Surgical, Inc.
EndoWrist One Vessel Sealer used in conjunction with the da Vinci Si Surgical System IS3000. The Endo Wrist One Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Si Surg
Terminated		 NAYK130266
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		 NAYK131861
Aug 8, 2014Intuitive Surgical, Inc.
EndoWrist Stapler System User Manual Addendum and Wall Chart; The EndoWrist Stapler 45 System and EndoWrist Stapler 45 Reloads are intended to be used with the da Vinci Si Surgical System (Model IS3
Terminated		 NAYK113706
Jul 8, 2014Intuitive Surgical, Inc.
Intuitive Surgical Inc. Large Clip Applier instruments used in conjunction with da Vinci S and da Vinci SI Surgical Systems Intuitive Surgical Inc., 'Sunnyvale, CA 94086
Terminated		 NAYK050369
Jul 4, 2014Intuitive Surgical, Inc.
Patient Side Cart Battery Box used in conjunction with the da Vinci A surgical system. Intuitive Surgical Inc. Sunnyvale, CA 94086
Terminated		 NAYK050369
K081137
Jul 2, 2014Intuitive Surgical, Inc.
Natural Rubber Latex QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System . Intuitive Surgical Endoscopic Instrument Control System.
Terminated		 NAYK021036
K050369 +1
Jul 2, 2014Intuitive Surgical, Inc.
Connection QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System . Intuitive Surgical Endoscopic Instrument Control System.
Terminated		 NAYK021036
K050369 +1
Jul 2, 2014Intuitive Surgical, Inc.
Cautery QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System . Intuitive Surgical Endoscopic Instrument Control System.
Terminated		 NAYK021036
K050369 +1
Jul 2, 2014Intuitive Surgical, Inc.
IRK QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System and Si-e. Intuitive Surgical Endoscopic Instrument Control System.
Terminated		 NAYK021036
K050369 +1
Jul 2, 2014Intuitive Surgical, Inc.
Single Site US Manuals and Single Site OUS Manuals for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.
Terminated		 NAYK021036
K050369 +1
Jul 2, 2014Intuitive Surgical, Inc.
Vessel Sealer QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.
Terminated		 NAYK021036
K050369 +1
Jul 2, 2014Intuitive Surgical, Inc.
Vessel Sealer Addendum for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.
Terminated		 NAYK021036
K050369 +1
Jul 2, 2014Intuitive Surgical, Inc.
Stapler Addendum for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.
Terminated		 NAYK021036
K050369 +1
Jul 2, 2014Intuitive Surgical, Inc.
Insert for IRK for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.
Terminated		 NAYK021036
K050369 +1
Jul 2, 2014Intuitive Surgical, Inc.
Vision Troubleshooting Guide for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.
Terminated		 NAYK021036
K050369 +1
Jul 2, 2014Intuitive Surgical, Inc.
Endowrist Instrument and Accessory Manual for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.
Terminated		 NAYK021036
K050369 +1
Jul 2, 2014Intuitive Surgical, Inc.
System Manual for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.
Terminated		 NAYK021036
K050369 +1
Jun 25, 2014Intuitive Surgical, Inc.
IS4000 da Vinci Xi - Endoscope accessory; 0 Degree, 8mm Endoscope. Intuitive Surgical Inc.
Terminated		 NAYNone listed
Jun 25, 2014Intuitive Surgical, Inc.
IS4000 da Vinci Xi - Endoscope accessory; 30 Degree, 8mm Endoscope. Intuitive Surgical Inc.
Terminated		 NAYK131861
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		 NAYK131861
Apr 4, 2014Intuitive Surgical, Inc.
5X250 MM Curved Cannula, Arm 2 for use with daVinci SI Surgical System, model number IS3000. Intuitive Surgical 1266 Kifer Road Sunnyvale, CA 94086 The Intuitive Surgical da Vinci Single-Site Instru
Terminated		 NAYK112208
Apr 4, 2014Intuitive Surgical, Inc.
5X250 MM Curved Cannula, Arm 1 for use with daVinci SI Surgical System, model number IS3000. Intuitive Surgical 1266 Kifer Road Sunnyvale, CA 94086 The Intuitive Surgical da Vinci Single-Site Instru
Terminated		 NAYK112208
Apr 4, 2014Intuitive Surgical, Inc.
5X300 MM Curved Cannula, Arm 2 for use with daVinci SI Surgical System, model number IS3000. Intuitive Surgical 1266 Kifer Road Sunnyvale, CA 94086 The Intuitive Surgical da Vinci Single-Site Instru
Terminated		 NAYK112208
Apr 4, 2014Intuitive Surgical, Inc.
5X300 MM Curved Cannula, Arm 1 for use with daVinci SI Surgical System, model number IS3000. Intuitive Surgical 1266 Kifer Road Sunnyvale, CA 94086 The Intuitive Surgical da Vinci Single-Site Instru
Terminated		 NAYK112208
Dec 16, 2013Intuitive Surgical, Inc.
Large Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, IS2000. Manufactured by Intuitive Surgical, Sunnyvale, CA. EndoWrist Instruments, including scissors, scalpels, forceps,
Terminated		 NAYK021036
K050369
Dec 16, 2013Intuitive Surgical, Inc.
Mega Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, IS2000. Manufactured by Intuitive Surgical, Sunnyvale, CA. EndoWrist Instruments, including scissors, scalpels, forceps,
Terminated		 NAYK021036
K050369
Dec 3, 2013Intuitive Surgical, Inc.
Assembly, Patient Side Manipulator on da Vinci Surgical Systems: da Vinci S Surgical System; da Vinci SI Surgical System da Vinci Si-e Surgical System; Manufactured by Intuitive Surgical Sunnyvale, C
Terminated		 NAYK050369
K081137
Nov 4, 2013Intuitive Surgical, Inc.
da Vinci Vision System Cart, a component of the da Vinci Si Surgical System IS3000; Y1903 Illuminator (Illuminator + Lamp Module); Y1902 Replacement Lamp Modules. Intuitive Surgical, Sunnyvale, CA.
Terminated		 NAYK081137

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