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
26-50 of 176
Cleared Dec 16, 2024
da Vinci Surgical System (IS5000)
K243641 · NAY
General & Plastic Surgery · 20d
Cleared Dec 10, 2024
IRISeg
K242461 · QIH
Radiology · 113d
Cleared CT Nov 26, 2024
da Vinci SP Surgical System (SP1098)
K242318 · NAY
General & Plastic Surgery · 113d
Cleared Nov 18, 2024
da Vinci SP Instruments (SP1098)
K241814 · NAY
General & Plastic Surgery · 147d
Cleared Sep 24, 2024
Ion Endoluminal System (IF 1000)
K242070 · EOQ
Ear, Nose, Throat · 70d
Cleared Sep 10, 2024
8mm SureForm 30 Curved-Tip Stapler
K241638 · NAY
General & Plastic Surgery · 95d
Cleared Aug 05, 2024
Universal Seal (5-12 mm)
K241360 · GCJ
General & Plastic Surgery · 83d
Cleared CT Jul 08, 2024
da Vinci SP Surgical System (SP1098)
K240502 · NAY
General & Plastic Surgery · 138d
Cleared Jul 03, 2024
da Vinci Surgical System (IS5000)
K241284 · NAY
General & Plastic Surgery · 57d
Cleared Jun 04, 2024
da Vinci SP Surgical System (SP1098)
K232773 · NAY
General & Plastic Surgery · 267d
Cleared Apr 03, 2024
Ion™ Endoluminal System (Ion™ Fully Articulating Catheter) (IF1000)
K240135 · EOQ
Ear, Nose, Throat · 76d
Cleared CT Mar 14, 2024
da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with...
K232610 · NAY
General & Plastic Surgery · 199d
Cleared Dec 18, 2023
Ion Endoluminal System (IF1000)
K232984 · EOQ
Ear, Nose, Throat · 87d
Cleared Nov 08, 2023
da Vinci SP Surgical System
K231798 · NAY
General & Plastic Surgery · 141d
Cleared Jul 05, 2023
Universal Seal (5-12 mm)
K231358 · GCJ
General & Plastic Surgery · 56d
Cleared May 12, 2023
da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)
K231224 · NAY
General & Plastic Surgery · 14d
Cleared Apr 05, 2023
Da Vinci SP Surgical System (SP1098)
K230033 · NAY
General & Plastic Surgery · 90d
Cleared Mar 16, 2023
EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System,...
K222839 · NAY
General & Plastic Surgery · 177d
Cleared Nov 22, 2022
da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System (IS4000)
K223080 · NAY
General & Plastic Surgery · 53d
Cleared Oct 20, 2022
da Vinci Firefly Imaging System
K222827 · NAY
General & Plastic Surgery · 31d
Cleared Aug 15, 2022
da Vinci X/Xi (IS4200/IS4000) 8mm Reusable Instruments
K214095 · NAY
General & Plastic Surgery · 230d
Cleared Jun 16, 2022
Ion Endoluminal System (IF1000)
K220299 · EOQ
Ear, Nose, Throat · 134d
Cleared Feb 17, 2022
da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System
K213710 · NAY
General & Plastic Surgery · 85d
Cleared Jan 31, 2022
8mm Monopolar Curved Scissors
K220023 · NAY
General & Plastic Surgery · 26d
Cleared Dec 10, 2021
8 mm SureForm 30 Curved-Tip Stapler, 8 mm SureForm 30 Stapler, SureForm 30...
K211997 · NAY
General & Plastic Surgery · 165d

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