Medical Device Manufacturer · US , Sunnyvale , CA

Intuitive Surgical, Inc. - FDA 510(k) Cleared Devices

176 submissions · 156 cleared · Since 1997
176
Total
156
Cleared
0
Denied
176 devices
101-125 of 176
Cleared Aug 07, 2016
da Vinci Xi Surgical System
K153276 · NAY
General & Plastic Surgery · 269d
Cleared Jul 11, 2016
da Vinci Xi Surgical System
K161271 · NAY
General & Plastic Surgery · 67d
Cleared Mar 30, 2016
da Vinci Surgical System, Model IS4000
K152578 · NAY
General & Plastic Surgery · 202d
Cleared Mar 09, 2016
da Vinci Single-Site Instrument and Accessories
K152448 · NAY
General & Plastic Surgery · 195d
Cleared Mar 04, 2016
IS4000 Stapler 30 Instrument and Stapler 30 Reloads
K152421 · NAY
General & Plastic Surgery · 191d
Cleared Jan 15, 2016
da Vinci Xi Surgical System
K151794 · NAY
General & Plastic Surgery · 198d
Cleared Jan 12, 2016
Endoscope Sterilization Tray
K151450 · KCT
General Hospital · 228d
Cleared Dec 09, 2015
da Vinci Xi Hasson Cone
K153126 · GCJ
General & Plastic Surgery · 41d
Cleared Oct 16, 2015
Bladeless Optical Obturators
K152663 · GCJ
General & Plastic Surgery · 29d
Cleared May 15, 2015
IS4000 da Vinci EndoWrist Instruments
K150284 · NAY
General & Plastic Surgery · 99d
Cleared Apr 29, 2015
IS4000 Small Clip Applier, IS4000 Long Bipolar Forceps
K150837 · NAY
General & Plastic Surgery · 30d
Cleared Apr 02, 2015
IS4000 8mm Harmonic ACE Curved Shears
K143132 · NAY
General & Plastic Surgery · 153d
Cleared Feb 24, 2015
Endoscope Sterilization Tray
K142937 · KCT
General Hospital · 138d
Cleared Dec 10, 2014
12 mm Endoscopes and Accessories
K142683 · NAY
General Hospital · 82d
Cleared Dec 03, 2014
12 mm & Stapler Bladeless Obturators
K143217 · NAY
General & Plastic Surgery · 23d
Cleared Sep 17, 2014
DA VINVI SURGICAL SYSTEM
K123329 · NAY
General & Plastic Surgery · 691d
Cleared Aug 12, 2014
DA VINCI FIREFLY IMAGING SYSTEM
K141077 · NAY
General & Plastic Surgery · 109d
Cleared Jul 25, 2014
ENDOWRIST STAPLER 45 AND STAPLER 45 RELOADS
K140553 · NAY
General & Plastic Surgery · 143d
Cleared Jun 05, 2014
ENDOWRIST VESSEL SEALER
K140189 · NAY
General & Plastic Surgery · 132d
Cleared May 09, 2014
SINGLE-SITE PORT
K133203 · GCJ
General & Plastic Surgery · 204d
Cleared Apr 17, 2014
DA VINCI SP SURGICAL SYSTEM, ENDOWRIST SP INSTRUMENTS, AND ACCESSORIES
K131962 · NAY
General & Plastic Surgery · 294d
Cleared Mar 28, 2014
DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIES
K131861 · NAY
General & Plastic Surgery · 277d
Cleared Jan 07, 2014
MONOPOLAR CAUTERY CORD, BIPOLAR CAUTERY CORD
K133167 · GEI
General & Plastic Surgery · 82d
Cleared Sep 13, 2013
DA VINCI FLUORESCENCE IMAGING VISION SYSTEM
K124031 · OWN
General & Plastic Surgery · 259d
Cleared Aug 29, 2013
ENDOWRIST ONE VESSEL SEALER
K130266 · NAY
General & Plastic Surgery · 206d

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