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)
Top companies in NAY
| Company | 510(k)s | Recalls |
|---|---|---|
| Intuitive Surgical | 148 | 246 |
| Transenterix, Inc. | 9 | 0 |
| Asensus Surgical | 6 | 1 |
| Aktormed GmbH | 2 | 0 |
| Computer Motion, Inc. | 2 | 0 |
| Olympus Corporation of the Americas | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 4, 2013 | Intuitive Surgical, Inc. Patient Cart used in conjunction with the da Vinci S surgical and SI System.
Intuitive Surgical
1266 Kifer Road
Sunnyvale, CA 94086
The Patient Side Cart (PSC) is a robotic platform used for da Vinc Terminated |
NAY | K050369 K081137 |
| Oct 30, 2013 | Intuitive Surgical, Inc. Single Site Curved Needed Driver
Intuitive Surgical, Sunnyvale, CA. 94086
The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) a Terminated |
NAY | K112208 |
| Oct 30, 2013 | Intuitive Surgical, Inc. Single Site Bipolar Maryland Forceps
Intuitive Surgical, Sunnyvale, CA. 94086
The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS300 Terminated |
NAY | K112208 |
| Oct 28, 2013 | Intuitive Surgical, Inc. da Vinci Si Surgical System IS3000 with the da Vinci Surgeon Console which contains a high Resolution Stereoscopic Viewer.
Intended to assist in the accurate control of Intuitive Surgical Endoscopic Terminated |
NAY | K081137 |
| Jul 11, 2013 | Intuitive Surgical, Inc. da Vinci Instrument Control Box, model number ICB3000;
Manufactured by Intuitive Surgical, Sunnyvale, CA 94086.
Intuitive Surgical endoscopic Instrument Control System is intended to assist in the a Terminated |
NAY | K110639 |
| Jul 11, 2013 | Intuitive Surgical, Inc. da Vinci Dual Camera Controller, model number DC3000;
Manufactured by Intuitive Surgical, Sunnyvale, CA 94086.
Intuitive Surgical endoscopic Instrument Control System is intended to assist in the ac Terminated |
NAY | K101077 |
| Jul 11, 2013 | Intuitive Surgical, Inc. da Vinci Si Vision System Cart, model number VS3000;
Manufactured by Intuitive Surgical, Sunnyvale, CA 94086.
Intuitive Surgical endoscopic Instrument Control System is intended to assist in the acc Terminated |
NAY | K081137 |
| Jul 11, 2013 | Intuitive Surgical, Inc. da Vinci Si Surgeon Side Cart, model number SS3000;
Manufactured by Intuitive Surgical, Sunnyvale, CA 94086.
Intuitive Surgical endoscopic Instrument Control System is intended to assist in the accu Terminated |
NAY | K081137 |
| Jun 5, 2013 | Intuitive Surgical, Inc. da Vinci 5 mm Flared Instrument Cannulae for use with the da Vinci S and Si Surgical Systems.
Used to establish a port of entry for Intuitive Surgical EndoWrist instruments Terminated |
NAY | None listed |
| Jun 5, 2013 | Intuitive Surgical, Inc. da Vinci 5 mm Instrument Cannulae for use with the da Vinci S and Si Surgical Systems.
Used to establish a port of entry for Intuitive Surgical EndoWrist instruments, Terminated |
NAY | K050369 K101743 |
| May 31, 2013 | Intuitive Surgical, Inc. 8 mm Monopolar Curved Scissors (a.k.a. Hot Shears)
Manufactured and Distributed by:
Intuitive Surgical
Sunny vale, CA
The EndoWrist Monopolar Curved Scissors Instrument is a multiple-use endoscopi Terminated |
NAY | K050005 |
| May 29, 2013 | Intuitive Surgical, Inc. 8mm Fenestrated Bipolar Forceps used in conjunction with the da Vinci Surgical System, Model IS1200.
Multiple use electrosurgical endoscopic instruments. Terminated |
NAY | K012833 |
| May 29, 2013 | Intuitive Surgical, Inc. 8mm Maryland Bipolar Forceps used in conjunction with the da Vinci Surgical System, Model IS1200.
Multiple use electrosurgical endoscopic instruments. Terminated |
NAY | K012833 |
| May 29, 2013 | Intuitive Surgical, Inc. 8mm Precise Bipolar Forceps used in conjunction with the da Vinci Surgical System, Model IS1200.
Multiple use electrosurgical endoscopic instruments. Terminated |
NAY | K012833 |
| May 29, 2013 | Intuitive Surgical, Inc. User Manual addendum, TORS for da Vinci Surgical System IS 1200, IS 2000 and IS 3000.
Product Usage:
The user manual for Transoral Surgery (TORS) provided information to update and replace the Indic Terminated |
NAY | K090993 |
| May 29, 2013 | Intuitive Surgical, Inc. da Vinci Si Surgeon Console.
Intended to assist in the accurate Control of Intuitive Surgical Endoscopic Instruments. Terminated |
NAY | K050369 |
| May 29, 2013 | Intuitive Surgical, Inc. Flush Port (used in almost all da Vinci instruments)
Assists in cleaning the instrument. Terminated |
NAY | K050369 |
| May 29, 2013 | Intuitive Surgical, Inc. Cannula 8MM Regular.
Provides the means of introduction and placement of an instrument or accessory into the human body. Terminated |
NAY | K050369 |
| May 29, 2013 | Intuitive Surgical, Inc. Tip Cover Accessory, 8 MM, MCS, box of 10
Product Usage:
The disposable Tip cover accessory is used in conjunction with the 8mm Monopolar Curved Scissors Instruments to cut and coagulate tissue. The Terminated |
NAY | K050005 |
| May 29, 2013 | Intuitive Surgical, Inc. Thyroidectomy Indication for the da Vinci Surgical Systems;
Product Usage:
da Vinci Thyroidectomy offers a minimally invasive surgery for both partial and total thyroidectomy procedures, including en Terminated |
NAY | K090993 |
| Apr 13, 2013 | Intuitive Surgical, Inc. IS3000 USER MANUAL for Intuitive Surgical da Vinci Si Surgical System and da Vinci Si-e Surgical System, Model SI3000.
Arm drapes protect equipment from contamination. Terminated |
NAY | K081137 |
| Apr 13, 2013 | Intuitive Surgical, Inc. IS2000 USER MANUAL for Intuitive Surgical da Vinci S Surgical System, Model IS2000.
Arm drapes protect equipment from contamination. Terminated |
NAY | K050369 |
| Sep 10, 2012 | Intuitive Surgical, Inc. Tip Cover for 8mm Monopolar Curved Scissors (Hot Shears)Accessory, Disposable, 8mm MCS, Box of 10.
The intended use of the Tip Cover Accessory is to provide dielectric insulation over a section of th Terminated |
NAY | K112263 |
| Jul 27, 2012 | Intuitive Surgical, Inc. ACCESSORY BASE STARTER KIT,IS3000;
Product Usage:
The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures Terminated |
NAY | K050369 |
| Jul 27, 2012 | Intuitive Surgical, Inc. KIT,DISPOSABLE ACCESSORY,4ARM,IS3000,5 PACK;
Product Usage:
The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical Terminated |
NAY | K050369 |
| Jul 27, 2012 | Intuitive Surgical, Inc. KIT,DISPOSABLE ACCESSORY,3ARM,IS3000,5 PACK;
Product Usage:
The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical p Terminated |
NAY | K050369 |
| Jul 27, 2012 | Intuitive Surgical, Inc. KIT,DISPOSABLE ACCESSORY,4ARM,IS2000,5 PACK;
Product Usage:
The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical p Terminated |
NAY | K050369 |
| Jul 27, 2012 | Intuitive Surgical, Inc. KIT,DISPOSABLE ACCESSORY,3ARM,IS2000,5 PACK;
Product Usage:
The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical p Terminated |
NAY | K050369 |
| Jul 27, 2012 | Intuitive Surgical, Inc. INSTRUMENT ARM DRAPE IS2000, 20 PACK:
Product Usage:
The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedur Terminated |
NAY | K050369 |
| Mar 13, 2012 | Intuitive Surgical, Inc. da Vinci S. Surgical System, da Vinci Si and da Vinci Si-e Surgical Systems.
Intuitive Surgical, Inc.
Sunnyvale, CA 94086.
The Intuitive Surgical Endoscopic instrument Control System is intended to Terminated |
NAY | K063220 K081137 |
| Aug 3, 2011 | Intuitive Surgical, Inc. Intuitive Surgical da Vinci Si Surgical System (IS3000);
Mfg by: Intuitive Surgical, Sunnyvale, CA 94086
Product Usage: Intended to assist in the accurate control of Intuitive Surgical Endoscopic E Terminated |
NAY | K090993 |
| Apr 5, 2010 | Intuitive Surgical, Inc. da Vinci S Surgical System IS2000 Endoscopic Instrument Control System, rev. A51_P7, manufactured by Intuitive Surgical, Sunnyvale, CA. Terminated |
NAY | K050369 |
| Sep 17, 2008 | Intuitive Surgical, Inc. INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODE; S Cardiac Probe Gasper Instrument, Model IS2000, Part Number 420215-02; Product is manufactured and distributed by Intuitive Surgical, Inc. Sunnyvale Terminated |
NAY | K070947 |
| Sep 16, 2008 | Intuitive Surgical, Inc. da Vinci S Surgical System, Model number IS2000 Endoscopic Instrument Control System, manufactured by Intuitive Surgical, Sunnyvale, CA. Terminated |
NAY | K050369 K060322 |
| Aug 6, 2008 | Intuitive Surgical, Inc. Da Vinci S 8mm Instrument Cannula with outlet for use with the Da Vinci Surgical System;
Model IS2000, Part Numbers: 400254-01, 400255-01;
Used in endoscopic surgery to establish a port of entry for Terminated |
NAY | None listed |
| Jun 12, 2008 | Intuitive Surgical, Inc. da Vinci S Surgical System, Model number IS2000 Revision number A51 P5; endoscopic surgical control system, Intuitive Surgical, Inc., Sunnyvale, CA 94086 Terminated |
NAY | K050369 |
| Feb 22, 2008 | Intuitive Surgical, Inc. Intuitive brand da Vinci S Surgical System, Endoscopic Instrument Control System, Model IS2000 with Isolation Transformer (P/N: 952012) and Vision Cart (Model: VS2000), Distributed and Manufactured by Terminated |
NAY | K021036 K050369 +2 |
| Feb 22, 2008 | Intuitive Surgical, Inc. Intuitive brand da Vinci S Surgical System, Endoscopic Instrument Control System, Model IS1200 with Isolation Transformer (P/N: 952012) and Vision Cart (Model VS1000), Distributed and Manufactured by: Terminated |
NAY | K021036 K050369 +2 |
| Feb 21, 2008 | Intuitive Surgical, Inc. Intuitive Surgical, daVinci S Surgical System, Model Number: IS2000, A5.1 P1 and A5.0 P5 software level, Surgical Endoscopic Instrument Control System, Intuitive Surgical, Sunnyvale, CA 94086. Terminated |
NAY | K050369 K060322 |
| Jan 31, 2008 | Intuitive Surgical, Inc. Intuitive brand da Vinci S, 5 mm Instrument Cannula
Model/Part Number: 420011-02, Product is manufactured and distributed by Intuitive Surgical , 950 Kifer Road,
Sunnyvale, CA Terminated |
NAY | K050369 |
| Jan 31, 2008 | Intuitive Surgical, Inc. da Vinci S Surgical System 5 mm instrument cannula, Part #: 420011-01, Intuitive Surgical, Inc., Sunnvale, Ca. 94086 Terminated |
NAY | K050369 |
| Jan 31, 2008 | Intuitive Surgical, Inc. da Vinci S Surgical System 8 mm Long instrument cannula, Part #:420004-01, Intuitive Surgical, Inc., Sunnvale, Ca. 94086, Terminated |
NAY | K050369 |
| Jan 31, 2008 | Intuitive Surgical, Inc. da Vinci S Surgical System 8 mm instrument cannula, Part #: 420002-01, Intuitive Surgical, Inc., Sunnvale, Ca. 94086 Terminated |
NAY | K050369 |
| Jan 24, 2008 | Intuitive Surgical, Inc. Intuitive Surgical EndoWrist, 8 mm, PK Dissecting Forceps for use with the da Vinci and da Vinci S Surgical systems, Part Numbers: 400214-02, 400214-03, 420214-02 and 420214-03, Intuitive Surgical, In Terminated |
NAY | K061260 |
| Sep 26, 2007 | Intuitive Surgical, Inc. daVinci S Surgical system, patient side cart Auxiliary power board (APB) (printed circuit board assembly), endoscopic instrument control system. Terminated |
NAY | K050369 K063220 |
| Sep 26, 2007 | Intuitive Surgical, Inc. Endoscopic Instrument Control System (da Vinci Surgical System) Model IS1200, A4.3 SW level, Manufactured by Intuitive Surgical, Inc, Sunnyvale, CA 94086 Terminated |
NAY | K021036 K990144 |
| Mar 29, 2007 | Intuitive Surgical, Inc. Intuitive brand Da Vinci S Surgical System, an Endoscopic Instrument Control System, Model SS2000 Patient Side Cart, Model PS2000, Part Number: 380267-01, IS2000, Top Level, 4-Arm; Distributed and Man Terminated |
NAY | K050369 |
| Mar 28, 2007 | Intuitive Surgical, Inc. 8mm EndoWrist Bipolar Maryland Instrument, Part Number: 400172-04,
Distributed and Manufactured by Intuitive Surgical, Inc. 950 Kifer Road Sunnyvale, CA Terminated |
NAY | K012833 |
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