Atlas FDA

INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS2000

FDA 510(k) clearance K050369 · decided 2005-04-29

Clearance details

K-number
K050369
Device name
INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS2000
Applicant
Intuitive Surgical, Inc.
Decision
Substantially Equivalent
Date received
2005-02-14
Decision date
2005-04-29
Days to decision
74 days
Clearance type
Traditional
Product code
NAY
Device class
2
Regulation number
876.1500
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Sunnyvale, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Brand Name: da Vinci S, Si Monopolar Curved Scissors Instrument Product Name: da Vinci S a recall (Z-1696-2026)Intuitive Surgical, Inc.2026-03-30
Brand Name: da Vinci S, Si Double Fenestrated Grasper Instrument Product Name: da Vinci S, recall (Z-1697-2026)Intuitive Surgical, Inc.2026-03-30
Brand Name: da Vinci S, Si Mega Needle Driver Instrument Product Name: da Vinci S, Si Mega recall (Z-1698-2026)Intuitive Surgical, Inc.2026-03-30
Brand Name: da Vinci S, Si Grasping Retractor Instrument Product Name: da Vinci S, Si Gras recall (Z-1699-2026)Intuitive Surgical, Inc.2026-03-30
Brand Name: da Vinci S, Si Tenaculum Forceps Instrument Product Name: da Vinci S, Si Tenac recall (Z-1700-2026)Intuitive Surgical, Inc.2026-03-30
Brand Name: da Vinci S, Si Permanent Cautery Hook Instrument Product Name: da Vinci S, Si recall (Z-1701-2026)Intuitive Surgical, Inc.2026-03-30
Thoracic Grasper, 5 MM, for use with da Vinci S (IS2000) and SI (IS3000) Surgical Systems. recall (Z-1812-2015)Intuitive Surgical, Inc.2015-06-17
Intuitive Surgical Inc. Large Clip Applier instruments used in conjunction with da Vinci S recall (Z-2020-2014)Intuitive Surgical, Inc.2014-07-08
Patient Side Cart Battery Box used in conjunction with the da Vinci A surgical system. Int recall (Z-1994-2014)Intuitive Surgical, Inc.2014-07-04
System Manual for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si recall (Z-1964-2014)Intuitive Surgical, Inc.2014-07-02
Endowrist Instrument and Accessory Manual for the da Vinci Standard Surgical System; da Vi recall (Z-1965-2014)Intuitive Surgical, Inc.2014-07-02
Vision Troubleshooting Guide for the da Vinci Standard Surgical System; da Vinci S System recall (Z-1966-2014)Intuitive Surgical, Inc.2014-07-02
Insert for IRK for the da Vinci Standard Surgical System; da Vinci S System and da Vinci S recall (Z-1967-2014)Intuitive Surgical, Inc.2014-07-02
Stapler Addendum for the da Vinci Standard Surgical System; da Vinci S System and da Vinci recall (Z-1968-2014)Intuitive Surgical, Inc.2014-07-02
Vessel Sealer Addendum for the da Vinci Standard Surgical System; da Vinci S System and da recall (Z-1969-2014)Intuitive Surgical, Inc.2014-07-02
Vessel Sealer QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinc recall (Z-1970-2014)Intuitive Surgical, Inc.2014-07-02
Single Site US Manuals and Single Site OUS Manuals for the da Vinci Standard Surgical Syst recall (Z-1971-2014)Intuitive Surgical, Inc.2014-07-02
IRK QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si Syste recall (Z-1972-2014)Intuitive Surgical, Inc.2014-07-02
Cautery QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si S recall (Z-1973-2014)Intuitive Surgical, Inc.2014-07-02
Connection QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci S recall (Z-1974-2014)Intuitive Surgical, Inc.2014-07-02
Natural Rubber Latex QRG for the da Vinci Standard Surgical System; da Vinci S System and recall (Z-1975-2014)Intuitive Surgical, Inc.2014-07-02
Mega Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, IS2000. Manufac recall (Z-0520-2014)Intuitive Surgical, Inc.2013-12-16
Large Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, IS2000. Manufa recall (Z-0521-2014)Intuitive Surgical, Inc.2013-12-16
Assembly, Patient Side Manipulator on da Vinci Surgical Systems: da Vinci S Surgical Syste recall (Z-0436-2014)Intuitive Surgical, Inc.2013-12-03
Patient Cart used in conjunction with the da Vinci S surgical and SI System. Intuitive Sur recall (Z-0139-2014)Intuitive Surgical, Inc.2013-11-04
da Vinci 5 mm Instrument Cannulae for use with the da Vinci S and Si Surgical Systems. Use recall (Z-1463-2013)Intuitive Surgical, Inc.2013-06-05
Cannula 8MM Regular. Provides the means of introduction and placement of an instrument or recall (Z-1427-2013)Intuitive Surgical, Inc.2013-05-29
Flush Port (used in almost all da Vinci instruments) Assists in cleaning the instrument. recall (Z-1428-2013)Intuitive Surgical, Inc.2013-05-29
da Vinci Si Surgeon Console. Intended to assist in the accurate Control of Intuitive Surgi recall (Z-1429-2013)Intuitive Surgical, Inc.2013-05-29
IS2000 USER MANUAL for Intuitive Surgical da Vinci S Surgical System, Model IS2000. Arm dr recall (Z-1109-2013)Intuitive Surgical, Inc.2013-04-13
INSTRUMENT ARM DRAPE IS2000, 20 PACK: Product Usage: The intended use of the Instrument ar recall (Z-2101-2012)Intuitive Surgical, Inc.2012-07-27
KIT,DISPOSABLE ACCESSORY,3ARM,IS2000,5 PACK; Product Usage: The intended use of the Instru recall (Z-2102-2012)Intuitive Surgical, Inc.2012-07-27
KIT,DISPOSABLE ACCESSORY,4ARM,IS2000,5 PACK; Product Usage: The intended use of the Instru recall (Z-2103-2012)Intuitive Surgical, Inc.2012-07-27
KIT,DISPOSABLE ACCESSORY,3ARM,IS3000,5 PACK; Product Usage: The intended use of the Instru recall (Z-2104-2012)Intuitive Surgical, Inc.2012-07-27
KIT,DISPOSABLE ACCESSORY,4ARM,IS3000,5 PACK; Product Usage: The intended use of the Instru recall (Z-2105-2012)Intuitive Surgical, Inc.2012-07-27
ACCESSORY BASE STARTER KIT,IS3000; Product Usage: The intended use of the Instrument arm d recall (Z-2106-2012)Intuitive Surgical, Inc.2012-07-27
da Vinci S Surgical System IS2000 Endoscopic Instrument Control System, rev. A51_P7, manuf recall (Z-1161-2010)Intuitive Surgical, Inc.2010-04-05
da Vinci S Surgical System, Model number IS2000 Endoscopic Instrument Control System, manu recall (Z-2204-2008)Intuitive Surgical, Inc.2008-09-16
da Vinci S Surgical System, Model number IS2000 Revision number A51 P5; endoscopic surgica recall (Z-1180-2008)Intuitive Surgical, Inc.2008-06-12
Intuitive brand da Vinci S Surgical System, Endoscopic Instrument Control System, Model IS recall (Z-0151-2008)Intuitive Surgical, Inc.2008-02-22
Intuitive brand da Vinci S Surgical System, Endoscopic Instrument Control System, Model IS recall (Z-0152-2008)Intuitive Surgical, Inc.2008-02-22
Intuitive Surgical, daVinci S Surgical System, Model Number: IS2000, A5.1 P1 and A5.0 P5 s recall (Z-0079-2008)Intuitive Surgical, Inc.2008-02-21
da Vinci S Surgical System 8 mm instrument cannula, Part #: 420002-01, Intuitive Surgical, recall (Z-0657-2008)Intuitive Surgical, Inc.2008-01-31
da Vinci S Surgical System 8 mm Long instrument cannula, Part #:420004-01, Intuitive Surgi recall (Z-0658-2008)Intuitive Surgical, Inc.2008-01-31
da Vinci S Surgical System 5 mm instrument cannula, Part #: 420011-01, Intuitive Surgical, recall (Z-0659-2008)Intuitive Surgical, Inc.2008-01-31
Intuitive brand da Vinci S, 5 mm Instrument Cannula Model/Part Number: 420011-02, Product recall (Z-0669-2008)Intuitive Surgical, Inc.2008-01-31
daVinci S Surgical system, patient side cart Auxiliary power board (APB) (printed circuit recall (Z-1245-2007)Intuitive Surgical, Inc.2007-09-26
Intuitive brand Da Vinci S Surgical System, an Endoscopic Instrument Control System, Model recall (Z-0670-2007)Intuitive Surgical, Inc.2007-03-29