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
51-75 of 176
Cleared Nov 23, 2021
da Vinci SP Firefly Imaging System
K212101 · NAY
General & Plastic Surgery · 140d
Cleared Sep 29, 2021
Da Vinci SP Surgical System
K212747 · NAY
General & Plastic Surgery · 30d
Cleared Aug 26, 2021
Ion Endoluminal System (Ion Fully Articulating Catheter), Ion Endoluminal...
K212048 · EOQ
Ear, Nose, Throat · 57d
Cleared Aug 06, 2021
da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)
K211784 · NAY
General & Plastic Surgery · 58d
Cleared Jul 23, 2021
da Vinci SP Surgical System (SP1098)
K211316 · NAY
General & Plastic Surgery · 84d
Cleared Jun 23, 2021
da Vinci SP Surgical System (SP1098)
K211595 · NAY
General & Plastic Surgery · 30d
Cleared Apr 26, 2021
da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System
K210918 · NAY
General & Plastic Surgery · 28d
Cleared Feb 10, 2021
da Vinci S/Si (IS2000/IS3000) 5mm and 8mm Reusable Instruments, da Vinci Xi/X...
K203632 · NAY
General & Plastic Surgery · 61d
Cleared Dec 22, 2020
Da Vinci SP Surgical System
K202968 · NAY
General & Plastic Surgery · 83d
Cleared Dec 10, 2020
da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)
K202834 · NAY
General & Plastic Surgery · 76d
Cleared Nov 16, 2020
Ion Endoluminal System
K202370 · EOQ
Ear, Nose, Throat · 89d
Cleared Nov 12, 2020
da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments, and...
K202571 · NAY
General & Plastic Surgery · 69d
Cleared Sep 28, 2020
da Vinci SP Surgical System
K192717 · NAY
General & Plastic Surgery · 367d
Cleared Jun 26, 2020
Ion Endoluminal System
K201146 · EOQ
Ear, Nose, Throat · 58d
Cleared Mar 31, 2020
da Vinci X and Xi Surgical System
K183086 · NAY
General & Plastic Surgery · 511d
Cleared Nov 26, 2019
Ion Endoluminal System
K192367 · EOQ
Ear, Nose, Throat · 88d
Cleared Nov 14, 2019
E-100 Electrosurgical Generator, SynchroSeal
K191280 · NAY
General & Plastic Surgery · 185d
Cleared Jul 12, 2019
SureForm 45 Curved Tip, SureForm 45 Gray Reload
K190999 · NAY
General & Plastic Surgery · 87d
Cleared Jun 06, 2019
da Vinci Handheld Camera
K191043 · GCJ
General & Plastic Surgery · 48d
Cleared Mar 14, 2019
da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories
K182371 · NAY
Ear, Nose, Throat · 195d
Cleared Feb 01, 2019
Endoscope Sterilization Tray
K183139 · KCT
General Hospital · 80d
Cleared Dec 11, 2018
Intuitive Surgical Vessel Sealer Extend
K183107 · NAY
General & Plastic Surgery · 33d
Cleared Oct 24, 2018
da Vinci Xi Surgical System, da Vinci X Surgical System
K182140 · NAY
General & Plastic Surgery · 78d
Cleared Sep 28, 2018
Endoscope Sterilization Tray
K180964 · KCT
General Hospital · 169d
Cleared Aug 07, 2018
EndoWrist Mercury Bipolar Grasper
K180351 · NAY
General & Plastic Surgery · 180d

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