Medical Device Manufacturer · US , Suunyvale , CA

Intuitive Surgical - FDA 510(k) Cleared Devices

17 submissions · 16 cleared · Since 2014

Recent clearances: da Vinci Firefly Imaging System, da Vinci E-200 Electrosurgical Generator, Da Vinci Monopolar and Bipolar Adapters (378896)

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17
Total
16
Cleared
0
Denied

Intuitive Surgical has 16 FDA 510(k) cleared general & plastic surgery devices. Based in Suunyvale, US.

Latest FDA clearance: May 2026. Active since 2014.

Browse the complete list of FDA 510(k) cleared general & plastic surgery devices from this manufacturer. Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - Intuitive Surgical

17 devices
1-17 of 17
Cleared May 22, 2026
da Vinci Firefly Imaging System
K260695 · NAY
General & Plastic Surgery · 80d
Cleared Aug 05, 2024
da Vinci E-200 Electrosurgical Generator
K241635 · GEI
General & Plastic Surgery · 60d
Cleared Aug 02, 2024
Da Vinci Monopolar and Bipolar Adapters (378896)
K241621 · GEI
General & Plastic Surgery · 58d
Cleared May 24, 2024
da Vinci Xi Surgical System (IS4000)
K240723 · NAY
General & Plastic Surgery · 67d
Cleared Jun 21, 2023
da Vinci E-200 Electrosurgical Generator
K231212 · GEI
General & Plastic Surgery · 54d
Cleared Nov 28, 2022
da Vinci E-200 Electrosurgical Generator
K223039 · GEI
General & Plastic Surgery · 60d
Cleared Apr 29, 2020
da Vinci Xi Surgical System, da Vinci X Surgical System
K192803 · NAY
General & Plastic Surgery · 212d
Cleared Feb 06, 2020
da Vinci Xi Surgical System, da Vinci X Surgical System
K191529 · NAY
General & Plastic Surgery · 241d
Cleared Jul 26, 2019
da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30
K191736 · NAY
General & Plastic Surgery · 28d
Cleared Feb 22, 2019
IRIS 1.0 System
K182643 · LLZ
Radiology · 151d
Cleared Feb 14, 2019
Ion Endoluminal System
K182188 · EOQ
Ear, Nose, Throat · 185d
Cleared Jan 18, 2019
SureForm 45, SureForm 45 Reloads
K183224 · NAY
General & Plastic Surgery · 59d
Cleared Jul 05, 2018
SureForm 60 and SureForm 60 Reloads
K173721 · NAY
General & Plastic Surgery · 212d
Cleared Apr 29, 2016
da Vinci Xi Surgical System
K152892 · NAY
General & Plastic Surgery · 212d
Cleared Sep 26, 2014
SINGLE-SITE WRISTED NEEDLE DRIVER
K141075 · NAY
General & Plastic Surgery · 154d
Cleared Aug 01, 2014
ENDOSCOPE STERILIZATION TRAY
K133942 · KCT
General Hospital · 221d
Cleared Feb 19, 2014
8MM TROCAR KIT
K133845 · GCJ
General & Plastic Surgery · 63d
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All17 General & Plastic Surgery 14 General Hospital 1 Ear, Nose, Throat 1 Radiology 1