Atlas FDA

INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM: MODEL IS3000

FDA 510(k) clearance K081137 · decided 2009-02-18

Clearance details

K-number
K081137
Device name
INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM: MODEL IS3000
Applicant
Intuitive Surgical, Inc.
Decision
Substantially Equivalent
Date received
2008-04-21
Decision date
2009-02-18
Days to decision
303 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
IS3000 Vision Side Cart (VSC) used in conjunction with the da Vinci Si Surgical System IS3 recall (Z-0940-2015)Intuitive Surgical, Inc.2015-01-07
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
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 Vision System Cart, a component of the da Vinci Si Surgical System IS3000; Y1903 recall (Z-0146-2014)Intuitive Surgical, Inc.2013-11-04
da Vinci Si Surgical System IS3000 with the da Vinci Surgeon Console which contains a high recall (Z-0088-2014)Intuitive Surgical, Inc.2013-10-28
da Vinci Si Surgeon Side Cart, model number SS3000; Manufactured by Intuitive Surgical, Su recall (Z-1686-2013)Intuitive Surgical, Inc.2013-07-11
da Vinci Si Vision System Cart, model number VS3000; Manufactured by Intuitive Surgical, S recall (Z-1687-2013)Intuitive Surgical, Inc.2013-07-11
IS3000 USER MANUAL for Intuitive Surgical da Vinci Si Surgical System and da Vinci Si-e Su recall (Z-1110-2013)Intuitive Surgical, Inc.2013-04-13
da Vinci S. Surgical System, da Vinci Si and da Vinci Si-e Surgical Systems. Intuitive Sur recall (Z-1202-2012)Intuitive Surgical, Inc.2012-03-13