Atlas FDA

INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS1000

FDA 510(k) clearance K021036 · decided 2002-06-26

Clearance details

K-number
K021036
Device name
INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS1000
Applicant
Intuitive Surgical, Inc.
Decision
Substantially Equivalent
Date received
2002-04-01
Decision date
2002-06-26
Days to decision
86 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
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
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
Endoscopic Instrument Control System (da Vinci Surgical System) Model IS1200, A4.3 SW leve recall (Z-1244-2007)Intuitive Surgical, Inc.2007-09-26
Intuiitve Surgical da Vinci 8 mm EndoWrist Curved Scissors, in box. All lots. P/N 400178-0 recall (Z-0723-05)Intuitive Surgical, Inc.2005-04-22