Intuitive Surgical is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Intuitive Surgical - FDA 510(k) Cleared Devices
Recent clearances: da Vinci Firefly Imaging System, da Vinci E-200 Electrosurgical Generator, Da Vinci Monopolar and Bipolar Adapters (378896)
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
Cleared
May 22, 2026
da Vinci Firefly Imaging System
General & Plastic Surgery
80d
Cleared
Aug 05, 2024
da Vinci E-200 Electrosurgical Generator
General & Plastic Surgery
60d
Cleared
Aug 02, 2024
Da Vinci Monopolar and Bipolar Adapters (378896)
General & Plastic Surgery
58d
Cleared
May 24, 2024
da Vinci Xi Surgical System (IS4000)
General & Plastic Surgery
67d
Cleared
Jun 21, 2023
da Vinci E-200 Electrosurgical Generator
General & Plastic Surgery
54d
Cleared
Nov 28, 2022
da Vinci E-200 Electrosurgical Generator
General & Plastic Surgery
60d
Cleared
Apr 29, 2020
da Vinci Xi Surgical System, da Vinci X Surgical System
General & Plastic Surgery
212d
Cleared
Feb 06, 2020
da Vinci Xi Surgical System, da Vinci X Surgical System
General & Plastic Surgery
241d
Cleared
Jul 26, 2019
da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30
General & Plastic Surgery
28d
Cleared
Feb 22, 2019
IRIS 1.0 System
Radiology
151d
Cleared
Feb 14, 2019
Ion Endoluminal System
Ear, Nose, Throat
185d
Cleared
Jan 18, 2019
SureForm 45, SureForm 45 Reloads
General & Plastic Surgery
59d